Home » Posts tagged 'drugs' (Page 7)
Tag Archives: drugs
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....FOR BLOG HOME CLICK HEREFlag and hits
ORGANIC SPECTROSCOPY
SUBSCRIBE
Subscribe in a reader
Enter your email address:
Delivered by FeedBurner
Subscribe to New Drug Approvals by Email
Recent Comments
 | shivkr2 on SPSR Excellence Award 2025 – S… |
 | Bonkasaurus on Infigratinib phosphate |
 | PALOVAROTENE | ORGAN… on Palovarotene |
| Pfizer just purchase… on Temanogrel | |
| Pfizer To Cash In On… on Temanogrel |
Actelion wins crucial FDA approval for next-gen lung disease drug Opsumit
MACITENTAN
N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N’-propylsulfamide, CAS NO 441798-33-0
Late on Friday the FDA came through with an approval for Actelion’s pulmonary arterial hypertension (PAH) drug Opsumit (macitentan), its next-gen successor to the franchise drug Tracleer.
Read more: Actelion wins crucial FDA approval for next-gen lung disease drug Opsumit – FierceBiotech http://www.fiercebiotech.com/story/actelion-wins-crucial-fda-approval-next-gen-lung-disease-drug-opsumit/2013-10-18#ixzz2i7tDhpZT
Subscribe at FierceBiotech
Macitentan (Opsumit® )is a novel dual endothelin receptor antagonist that resulted from a tailored drug discovery process. Macitentan has a number of potentially key beneficial characteristics – i.e., increased in vivo preclinical efficacy vs. existing ERAs resulting from sustained receptor binding and tissue penetration properties. A clinical pharmacology program indicated a low propensity of macitentan for drug-drug interactions.
Macitentan is an investigational drug being studied for the treatment of pulmonary arterial hypertension. It acts as a dualendothelin receptor antagonist and is being developed by Actelion.[1] A Phase III clinical trial was successfully completed in 2012.[2]
on 22 October 2012 – Actelion (SIX: ATLN) announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension
Actelion’s experimental lung drug macitentan prolonged overall survival by more than a third according to detailed study data, which the company hopes will convince investors it has a viable follow-up product to secure its commercial future.
Europe’s largest standalone biotech company wants the drug, which treats pulmonary arterial hypertension — a disease that causes high blood pressure in the arteries of the lungs — to replace blockbuster Tracleer.
Tracleer currently makes up 87 percent of sales but loses patent protection in 2015 and has also seen its market share eroded by Gilead’s Letairis.
Pharmacokinetics
Macitentan has an active metabolite, ACT-132577, which is an oxidative depropylation product. Both macitentan and ACT-132577 are mainly excreted in form of hydrolysis products via urine (about 2/3 of all metabolites) and faeces (1/3).[3]
Co-administration of ciclosporin has only a slight effect on the concentrations of macitentan and its active metabolite, whilerifampicin decreases the area under the curve (AUC) of the drug’s blood plasma concentration by 79%, and ketoconazoleapproximately doubles it. This corresponds to the finding that macitentan is mainly metabolised via the liver enzyme CYP3A4.[4]
- ^ Bolli, M. H.; Boss, C.; Binkert, C.; Buchmann, S.; Bur, D.; Hess, P.; Iglarz, M.; Meyer, S.; Rein, J.; Rey, M.; Treiber, A.; Clozel, M.; Fischli, W.; Weller, T. (2012). “The Discovery of N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N′-propylsulfamide (Macitentan), an Orally Active, Potent Dual Endothelin Receptor Antagonist”. Journal of Medicinal Chemistry 55 (17): 7849–7861. doi:10.1021/jm3009103. PMID 22862294. edit
- ^ “Macitentan”. Actelion. Retrieved 22 August 2012.
- ^ Bruderer, S.; Hopfgartner, G. R.; Seiberling, M.; Wank, J.; Sidharta, P. N.; Treiber, A.; Dingemanse, J. (2012). “Absorption, distribution, metabolism, and excretion of macitentan, a dual endothelin receptor antagonist, in humans”. Xenobiotica 42 (9): 901–910.doi:10.3109/00498254.2012.664665. PMID 22458347. edit
- ^ Bruderer, S.; Äänismaa, P. I.; Homery, M. C.; Häusler, S.; Landskroner, K.; Sidharta, P. N.; Treiber, A.; Dingemanse, J. (2011).“Effect of Cyclosporine and Rifampin on the Pharmacokinetics of Macitentan, a Tissue-Targeting Dual Endothelin Receptor Antagonist”. The AAPS Journal 14 (1): 68–78. doi:10.1208/s12248-011-9316-3. PMC 3282010. PMID 22189899. edit
External links
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion’s first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium – the single layer of cells separating every blood vessel from the blood stream. Actelion’s over 2,400 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®).
Characterization of the “hygroscopic” properties of active pharmaceutical ingredients
Characterization of the “hygroscopic” properties of active pharmaceutical ingredients.
Source
SSCI, Inc., West Lafayette, IN, USA. ann.newman@aptuit.com
http://www.ncbi.nlm.nih.gov/pubmed/17630643
Abstract
The amount of water vapor taken up by an active pharmaceutical ingredient (API) as a function of relative humidity is routinely evaluated to characterize and monitor its “hygroscopicity” throughout the drug development process. In this minireview we address the necessity of going beyond the measurement of water vapor sorption isotherms to establish the various mechanisms by which solids interact with water and the important role played by the crystalline or amorphous form of the solid. Practical approaches for choosing experimental conditions under which water vapor sorption should be measured, including the pre-treatment of samples and the time allowed to reach an equilibrium state are presented. With the assistance of a flowchart, we provide a basis for the systematic examination of samples to establish the likely mechanisms of sorption and the indicators pointing toward future problems with physical and chemical instabilities. Finally, we present strategies for managing materials that might be susceptible to the detrimental effects of water vapor sorption.
(Copyright) 2008 Wiley-Liss, Inc.
Monoclonal antibody (mAbs) 2013
2013——-29 monoclonal antibody (mAbs) drugs are in Phase III clinical development.
While around 350 therapeutic mAbs are currently in clinical development globally, only 28 had entered active Phase 2/3 or Phase 3 studies as of January 2013, Additionally one mAb mixture was under evaluation in Phase III.
Historically, mAbs that target antigens relevant to cancer have comprised approximately 50% of the mAb clinical pipeline,
but in 2013 the picture has changed: 66% or 19 of the antibodies to watch in 2013 are for non-cancer indications.
The non-cancer mAbs include alirocumab (Regeneron; Sanofi, hypercholesterinemia);
AMG 145 (Amgen, hypercholesterinemia),
epratuzumab (UCB, SLE),
gantenerumab (Roche; Alzheimer’s disease),
gevokizumab (Xoma/Servier, Non-infectious uveitis),
itolizumab (Biocon, Plaque psoriasis), ixekizumab (Eli Lilly and Co., psoriasis),
lebrikizumab (Roche/Genentech, rheumatoid arthritis),
mepolizumab (GSK, Asthma, COPD etc.),
ocrelizumab (Roche/Genentech, multiple sclerosis),
reslizumab (Teva, Eosinophilic asthma), romosozumab (Amgen, Postmenopausal osteoporosis),
sarilumab (Regeneron; Sanofi, rheumatoid arthritis),
secukinumab (Novartis, rheuma, psoriasis),
sirukumab (Janssen R&D LLC, rheumatoid arthritis),
solanezumab (Eli Lilly and Co., Alzheimer’s disease),
tabalumab (Eli Lilly and Co., rheuma, SLE)
and
vedolizumab (Millenium, Ulcerative colitis; Crohn disease).
The mixture of actoxumab and bezlotoxumab (MK-3415A, Merck & Co.) is being evaluated in two Phase 3 studies as a treatment for Clostridium difficile infection.
The ten cancer mAbs are:
elotuzumab (Bristol-Myers Squibb, Abbott, multiple myeloma),
farletuzumab (Morphotek, ovarian cancer),
inotuzumab ozogamicin (Pfizer; UCB, ALL, NHL),
naptumomab estafenatox (Active Biotech, renal cell carcinoma),
necitumumab (ImClone LLC, NSCL),
nivolumab (Bristol-Myers Squibb, NSCL, renal cell carcinoma),
obinutuzumab (Roche/Genetech, Diffuse large B cell lymphoma, CLL, NHL),
onartuzumab (Roche/Genetech, NSCL cancer; gastric cancer),
racotumomab (CIMAB; Laboratorio Elea S.A.C.I.F. y A, NSCL),
and ramucirumab (ImClone LLC, Gastric; liver, breast, colorectal, NSCL cancers).
Antibody
Teva: FDA Approves of Generic Tobi in US
TOBRAMYCIN
JERUSALEM–(BUSINESS WIRE)–Oct. 14, 2013– Teva Pharmaceutical Industries Ltd. announces today that the U.S. Food and Drug Administration has granted approval of the generic equivalent to Tobi® (Tobramycin Inhalation Solution USP) in the United States. Pursuant to an agreement with Novartis on this product, Teva expects to launch this product in late November. Marketed by Novartis, Tobi had annual sales of approximately $350 million in the United States, according to IMS data as of June 30, 2013. READ ALL AT………..
http://www.drugs.com/news/teva-fda-approves-tobi-us-48168.html
Tobramycin is an aminoglycoside antibiotic derived from Streptomyces tenebrarius and used to treat various types of bacteria infections, particularly Gram-negative infections. It is especially effective against species of Pseudomonas.[1]
Tobramycin works by binding to a site on the bacterial 30S and 50S ribosome, preventing formation of the 70S complex. As a result, mRNA cannot be translated into protein and cell death ensues. Tobramycin is preferred over gentamicin for Pseudomonas aeruginosapneumonia due to better lung penetration.
Like all aminoglycosides, tobramycin does not pass the gastro-intestinal tract, so forsystemic use it can only be given intravenously or intramuscularly. Ophthalmic (tobramycin only, Tobrex, or combined with dexamethasone, sold as TobraDex) and nebulised formulations both have low systemic absorption. The formulation for injection is branded Nebcin. The nebulised formulation (brand name Tobi) is indicated in the treatment of exacerbations of chronic infection with Pseudomonas aeruginosa in patients diagnosed with cystic fibrosis. A proprietary formulation of micronized, nebulized tobramycin has been tested as a treatment for bacterial sinusitis.[2] Tobrex is a 0.3% tobramycin sterile ophthalmic solution is produced by Bausch & Lomb Pharmaceuticals. Benzalkonium chloride 0.01% is added as a preservative. It is available by prescription only in the United States and Canada. In certain countries, such as Italy, it is available over the counter. Tobrex and TobraDex are indicated in the treatment of superficial infections of the eye, such as bacterial conjunctivitis. Tobramycin (injection) is also indicated for various severe or life-threatening gram-negative infections : meningitis in neonates, brucellosis, pelvic inflammatory disease, Yersinia pestis infection (plague).
Like other aminoglycosides, tobramycin is ototoxic: it can cause hearing loss, or a loss ofequilibrioception, or both in genetically susceptible individuals. These individuals carry a normally harmless genetic mutation that allows aminoglycosides such as tobramycin to affect cochlear cells. Aminoglycoside-induced ototoxicity is generally irreversible.
As with all aminoglycosides, tobramycin is also nephrotoxic, meaning it is toxic to thekidneys. This effect can be particularly worrisome when multiple doses accumulate over the course of a treatment or when the kidney concentrates urine by increasing tubular reabsorption during sleep. Adequate hydration may help prevent excess nephrotoxicity and subsequent loss of renal function. For these reasons parenteral tobramycin needs to be carefully dosed by body weight, and its serum concentration monitored. Tobramycin is thus said to be a drug with a narrow therapeutic index.
|
Mass-spectrum of tobramycin |
|
|
- “Tobramycin” (pdf). Toku-E. 2010-01-12. Retrieved 2012-06-11.
- “Nebulized Tobramycin in treating bacterial Sinusitis” (Press release). July 22, 2008. Retrieved 2009-12-06.
A widely accepted therapy for treating respiratory infections caused by Gram- negative bacteria involves intravenous administration of a single antibiotic or combinations of antibiotics. Gibson et al., 2003 Am. J. Respir. Crit. Care. Med.
168(8):918-951 ; Ramsey, 1996 N. Engl. J. Med. 335(3): 179-188. However, this method of treatment has several significant limitations including: (1 ) narrow spectrum of activity of existing antibiotics, (2) insufficient concentrations of antibiotic reaching the respiratory tract to ensure rapid onset and high rates of bacterial killing, and (3) development of adverse side effects due to high systemic concentrations of drug.
Aerosol administration of antibiotics (Conway, 2005 Chronic Repir. Dis. 2:35- 41 ; O’Riordan, 2000 Respir. Care 45(7):836-845) addresses several of the limitations of parenteral administration (Flume and Klepser, 2002 Pharmacotherapy 22(3 Pt 2):71 S-79S; Kuhn, 2001 Chest. 120:94S-98S). It enables topical delivery of high concentrations of drug to the endobronchial spaces and reduces side effects by lowering systemic exposure to antibiotic. However, patients having chronic respiratory conditions, such as chronic obstructive pulmonary disease, cystic fibrosis and bronchiestasis, may receive prolonged and repeated antibiotic therapies over the entire duration of their adult lives. Gibson et al., 2003 Am. J. Respir. Crit. Care. Med. 168(8):918-951 ; Ramsey, 1996 N. Engi. J. Med. 335(3): 179-188. Therefore, cumulative antibiotic toxicity and development of resistance remains a significant problem. Chronic obstructive pulmonary disease (COPD), a smoking-related condition characterized by progressive and poorly reversible airflow obstruction and airway inflammation, is the fourth most common cause of death in developed countries. COPD is projected to be the third leading cause of global deaths in 2020 and is the only one of the four most common causes of death with an increasing mortality rate. In 2008 in the United States, there were an estimated 10 million patients diagnosed with chronic obstructive pulmonary disease (COPD). SDI COPD Claims Analysis, May 2009. Murray et at., 1997 Lancer 349: 1269-76. Approximately 7 million U.S. patients receive treatment for COPD. Mannino et al; The Epidemiology and
Economics of COPD, Proc Am Tho e Soc 2007. In the US, direct COPD costs in 2002 were approximately $18.0 billion. Statistics from National Center for Health Statistics, National Health Interview Survey: Research for the 1995-2004 redesign, Hyattsville, Maryland: U.S. Department of Health and Human Services, CDC, NCHS. Vital and Health Stat 2( 26), 1999.
The clinical course of COPD is characterized by chronic disability, with intermittent, acute exacerbations which may be triggered by a variety of stimuli including exposure to pathogens, inhaled irritants (e.g., cigarette smoke), allergens, or pollutants. “Acute exacerbation” refers to worsening of a patient’s COPD symptoms from his or her usual state that is beyond normal day-to-day variations, and is acute in onset. See, Rabe et al., 2007 Am J Res Crit Care Med, 176: 532- 555. Acute exacerbations of COPD greatly affect the health and quality of life of patients with COPD. Bathoorn, E, Int J Chron Obstruct Pulmon Dis. 2008 3(2):217- 229. Acute exacerbation of COPD is a key driver of the associated substantial socioeconomic costs of the disease. Approximately 73% ($13 billion) of direct COPD costs in 2002 were due to hospitalizations related to acute exacerbations of COPD. Investigators from the Burden of Obstructive Lung Disease (BOLD) Initiative have estimated the cumulative discounted cost of COPD care in the US to be $880 billion by 2020 – an average of more than $44 billion per year over two decades. Lee et al., 2006 ATS Proceedings, 3:A598. Multiple studies have also shown that prior exacerbation is an independent risk factor for future hospitalization for COPD.
Garcia-Aymerich et al., 2003, Thorax, 58:100-105. Hospitalization consumes roughly 70% of COPD healthcare expenditure in the US. McGhan et al., 2007, Chest, 132(6): 1748-1755. Accordingly, for a new drug therapy to significantly reduce the health and economic costs of COPD, it must address acute exacerbations of COPD.
It is clear that there is a continued need for an improved method of treatment for acute and chronic respiratory infections caused by Gram-negative and Gram- positive bacteria, particularly multidrug resistant bacteria, such as P. aeruginosa. This is particularly evident in patients having chronic respiratory conditions where current therapies are limited by problems with development of resistance and toxicity. Such method of treatment would preferably comprise inhalation of an aerosolized antibiotic composition that delivers a therapeutically effective amount of the active pharmaceutical ingredients directly to the endobronchial space of the airways or to the nasal passages. Such treatment would ideally be efficacious, reduce the frequency of drug resistance, and improve safety.
PCT Publication No. WO2005/1 0022 to Gilead Sciences, Inc. (formerly Corus Pharma) discloses a fosfomycin plus tobramycin combination formulation for delivery by aerosolization. The concentrated fosfomycin/tobramycin combination formulation containing an efficacious amount of fosfomycin and tobramycin is able to inhibit susceptible bacteria. Fosfomycin and tobramycin are formulated in solution such that when reconstituted, the pH is between 4.5 and 8.0 or as a dry powder. Also disclosed is a method for treatment of respiratory tract infections by a formulation delivered as an aerosol having mass medium aerodynamic diameter predominantly from 1 to 5 microns, produced by a jet or ultrasonic nebulizer (or equivalent) or dry powder inhaler.
tobramycin solution for inhalation of various formulations are described in the prior art. 例如，美国专利第5，508，269号公开了一种制剂，该制剂包括在Iml的盐水中40_100mg (毫克)的氨基糖苷被稀释成四分之一生理盐水强度，该制剂的PH值在5. 5到6. 5之间，其中该溶液以5ml浓缩形式气雾给药。 For example, U.S. Patent No. 5,508,269 discloses a preparation which is included in the brine Iml 40_100mg (mg) was diluted into a quarter normal saline aminoglycoside strength, the PH value of the preparation of 5 . 5 to 6.5 between, wherein the solution in concentrated form 5ml aerosol administration. [0011] 美国专利6987094公开了一种气雾制剂，其包括75mg/ml妥布霉素的水性溶液，该溶液包括O. 45%w/v (质量/体积百分比）的氯化钠，该制剂的pH值在4. O到5. 5之间，而渗透压在250到450m0sm/l (毫渗透克分子/毫升)。[0011] U.S. Patent 6,987,094 discloses an aerosol formulation which comprises an aqueous solution of 75mg/ml tobramycin, the solution comprises O. 45% w / v (mass / volume) of sodium chloride, the preparation the pH value of 4. O to 5.5, between the osmotic pressure of 250 to 450m0sm / l (mg penetration mol / ml). [0012] 美国专利申请2007/0116649公开了一种气雾制剂，其包括约100mg/ml到200mg/ ml的抗革兰阴性抗生素。 [0012] U.S. Patent Application 2007/0116649 discloses an aerosol formulation comprising about 100mg/ml to 200mg / ml of antibiotics against gram-negative. 提到了妥布霉素制剂，但是没有公开有妥布霉素的实验。Tobramycin formulations mentioned, but there is no disclosure tobramycin experiment. [0013] 美国专利申请2007/0071686公开了一种妥布霉素组合物，其包括约80mg/ml到120mg/ml的妥布霉素、一酸性辅助剂和低浓度的氯化钠。[0013] U.S. Patent Application 2007/0071686 discloses a tobramycin composition comprises about 80mg/ml to 120mg/ml of tobramycin, an acidic auxiliary agents and a low concentration of sodium chloride. 所述酸性辅助剂可以是硫酸钠或磷酸钠。 The acidic auxiliary agent may be sodium or sodium phosphate. 根据US2007/0071686，活性剂的浓度不超过120mg/ml，这是因为据说妥布霉素的浓度因粘度原因对雾化有负面影响。According to US2007/0071686, the concentration of the active agent is not more than 120mg/ml, this is because the concentration of tobramycin said reasons due to the viscosity of a negative impact on atomization. 而且，根据US2007/0071686的妥布霉素组合物利用喷雾器给药给患者，即活性成分通过潮式呼吸吸入。Moreover, the composition according to US2007/0071686 of tobramycin administered to patients using the spray, that the active ingredient through the tidal breathing inhalation. [0014] 欧洲专利2186508尤其公开了一种少于4ml溶液的组合物，其包括的60 – 200mg/ ml的、在生理上可接受的载体上的氨基糖苷抗生素。 [0014] In particular, in European Patent 2,186,508 discloses a composition of the solution is less than 4ml, comprising of 60 – 200mg / ml, and in a physiologically acceptable carrier aminoglycoside antibiotics. EP2186508中的实验显示，包括120mg/ ml妥布霉素的组合物使用PARI LC PLUS®牌喷雾器(德国Starnberg的Pari Boy N压缩器公司）给药需要约10分钟。EP2186508 The experiments showed that including 120mg / ml tobramycin compositions using PARI LC PLUS ® brand spray (Starnberg, Germany The Pari Boy N compressor company) to about 10 minutes of administration. 尽管这少于商业上可获得的TOBI®给药所需的时间,但从患者配合度和患者友好角度考虑，所需的时间还是太长。 Although this is less than the commercially available TOBI ® dosing time required, but with the degree of the patient, and patient-friendly point of view, the time is too long. EP2186508提到，使用呼吸致动吸入装置对于前面提到的商业上可获得的系统可以获得更快的给药时间。 EP2186508 mentioned breath actuated inhalation device used for the previously mentioned commercially available systems can be obtained faster delivery time. 但是，EP2186508 中使用呼吸致动吸入装置（AcroDose™)所获得的给药时间的实验仅限于低浓度的妥布霉素（60mg/ml)。However, EP2186508 using the breath actuated inhaler device (AcroDose ™) obtained experimental delivery time is limited to low concentrations of tobramycin (60mg/ml). 其还指出，使用AcroDose™系统的60mg/ml组合物给药,还必须给药第二可分量。 It also noted that the use AcroDose ™ system 60mg/ml composition administered may also be administered a second component. 从患者友好和配合角度来看，需要加入和给药第二可分量代表一种缺点。 Friendship and cooperation from the patient’s point of view, and the administration need to add a second component represents a drawback can be. [0015] 妥布霉素溶液也以局部给药出名，例如治疗角膜炎，参见Davis等人在“Canad. J Ophtal. ”(加拿大眼科杂志，1978年第13期273页)的文章,Davis等人在“Arch Opthalmol” (眼科杂志，1978年第96卷123-125页)的文章和Unter man等人在“ J. Cataract Refract. Surg. ”（白内障手术杂志，1988年第14卷500-504页）的文章。[0015] tobramycin solution is also famous for topical administration, such as treatment keratitis, see Davis et al in “Canad. J Ophtal.” (Canadian Journal of Ophthalmology, 1978 13 273) of the article, Davis, etc. in “Arch Opthalmol” (Ophthalmology 1978 Volume 96 pages 123-125) of articles and Unter man and others in “J. Cataract Refract. Surg.” (cataract surgery magazine, Volume 14, 500-504, 1988 pages) of the article. [0016] 现有给药手段和治疗方案的公知缺点是给药所需的时间，尤其影响患者的配合度和患者的生活质量。 Existing methods of administration and treatment programs known
NEW DRUG APPROVALS ACHIEVES ONE LAKH VIEWS IN 166 COUNTRIES
DR A .M. CRASTO
THIS BLOG NEW DRUG APPROVALS ACHIEVES ONE LAKH VIEWS IN 166 COUNTRIES …………….16 TH OCT 2013
BioDelivery Sciences Announces FDA Acceptance of Bunavail NDA for Filing
buprenorphine
naloxone
RALEIGH, N.C., Oct. 9, 2013 /PRNewswire/ — BioDelivery Sciences International, Inc. announced today that its New Drug Application (NDA) for Bunavail (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review. Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the Bunavail NDA is expected to be completed by early June 2014.
FDA Approves Sanofi’s Nasacort® Allergy 24HR for Over-the-Counter Use – Nasal Spray Treats Adults and Children with Seasonal and Year-Round Nasal Allergies
Nasacort
Paris, France, October 11, 2013 — Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) approved Nasacort® Allergy 24HR nasal spray as an over-the-counter (OTC) treatment for seasonal and year-round nasal allergies in adults and children 2 years of age and older. Nasacort is the first and only medicine in its class to be available without a prescription and will be marketed by Sanofi’s consumer healthcare division, Chattem, Inc.
read all at
http://www.pharmalive.com/fda-oks-otc-nasacort-allergy-24hr
Triamcinolone acetonide, USP, the active ingredient in NASACORT AQ Nasal Spray, is a corticosteroid with a molecular weight of 434.51 and with the chemical designation 9-Fluoro11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (C24H31FO6).
 |
NASACORT AQ Nasal Spray is a thixotropic, water-based metered-dose pump spray formulation unit containing a microcrystalline suspension of triamcinolone acetonide in an aqueous medium. Microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dextrose, benzalkonium chloride, and edetate disodium are contained in this aqueous medium; hydrochloric acid or sodium hydroxide may be added to adjust the pH to a target of 5.0 within a range of 4.5 and 6.0.
Unani medicine
Unani-tibb or Unani Medicine also spelled Yunani Medicine (/juːˈnɑːni/; Yūnānī in Arabic, Hindustani, pashto and Persian) is a form oftraditional medicine widely practiced by Muslims. It refers to a tradition of Graeco-Arabic medicine, which is based on the teachings of Greek physician Hippocrates, and Roman physician Galen, and developed into an elaborate medical System by Arab and Persian physicians, such asRhazes (al-Razi), Avicenna (Ibn Sena), Al-Zahrawi, and Ibn Nafis.
Unani medicine is based on the concept of the four humours: Phlegm (Balgham), Blood (Dam), Yellow bile (Ṣafrā’) and Black bile (Saudā’).
The word Unani or Yunani has its origins in the Greek word Ἰωνία (Iōnía) or Ἰωνίη (Iōníe), a place name given to a Greek populated coastal region of Ionian Sea.
History of Unani Medicine
The Origin of Unani system of medicine Is from Greece. The term ‘UNANI’ is derived from the word ‘UNAN’ or “YUNAN” which means Greece in Arabic Its also know as Greco-Arab medicine. the treatment of Unani is based on teachings of Hippocrates It was the work of the Greek philosopher-physician Hippocrates {Buqrat In Arabic} (460-377 B.C.), who freed medicine from the realm of superstition and magic and gave it the status of science. He considered illness to be natural rather than a supernatural phenomenon, and he felt that medicine should be administered without ritual ceremonies or magic.By his method of careful study and comparison of symptoms, he laid the foundation for clinical medicine.
Hippocrates
After Hippocrates Many scholars enriched the system of Unani Medicine. Of them Galen {Jalinus in Arabic} (131-200 A.D.) stands out as the one who established its foundation on which Arab physicians like Rhazes {Al-Razi in Arabic} (850-932 A.D.) and Avicenna {Ibn-Sena in Arabic} (980-1037 A.D.) constructed an imposing edifice. Galen introduced and practiced the Unani system of medicine in pre-Islamic Egypt, researched, experimented and developed hundreds of new medicines and cures for almost all types of diseases.
Unani medicine was the first to establish that disease was a natural process and that symptoms were the reactions of the body to the disease. It believes in the humeral theory which presupposes the presence of the four humors – Dam (blood), Balgham(phlegm), Safra (yellow bile) and Sauda (black bile) in the body. Each humor has its own temperament – blood is hot and moist, phlegm cold and moist, yellow bile hot and dry and black bile cold and dry. Every person attains a temperament according to the preponderance in them of the humors which represent the person’s healthy state, which are expressed as sanguine, phlegmatic, choleric and melancholic.
It was further enriched by imbibing the best of contemporary systems of medicine in the middle eastern and far eastern countries like Egypt, Syria, Iraq, Persia, India, China and other Middle East and Far East countries enriched the Unani system. That is why this system is known, in different parts of the world, with different names such as Greco-Arab Medicine, Ionian Medicine, Arab Medicine, Islamic Medicine, Traditional Medicine, Oriental Medicine, etc.
A Unani physician does not prescribe the strongest drug at the beginning of the treatment. He selects the drug according to the degree of variation from the normal healthy condition and observes the effect produced by the treatment. At the same time, he instructs the patient to observe some restrictions in diet and lifestyle.“Besides the use of herbs for treatment, Unani medicine employs a variety of other techniques intended to cleanse the body and restore humor balance. These techniques include: mushil (purging), taareeq (sweating), hammam (bath therapy), munzij (ripening), mahajim (cupping) and riyazat (exercise).
Though the threads which comprise Unani healing can be traced all the way back to Ancient Iranian Medicine, the basic knowledge of Unani medicine as a healing system was developed by Muslim scholar Hakim Ibn Sina (known as Avicenna in the west) in his medical encyclopedia The Canon of Medicine. The time of origin is thus dated at circa 1025 AD, when Avicenna wrote The Canon of Medicine in Persia. While he was primarily influenced by Greek and Islamic medicine, he was also influenced by the Indian medical teachings of Sushruta and Charaka.
Unani medicine first arrived in India around 12th or 13th century with establishment of Delhi Sultanate (1206-1527) and Islamic rule over North India and subsequently flourished under Mughal Empire. Alauddin Khilji (r. 1296-1316) had several eminent Unani physicians (Hakims) in his royal courts In the coming year this royal patronage meant development of Unani practice in India, but also of Unani literature with the aid of Indian Ayurvedic physicians.
Diagnosis and treatment
Fortunately, Unani classical literature consists of thousands of books and contains vast knowledge and mention of experiences on all aspects of medicine. According to Unani medicine, management of any disease depends upon the diagnosis of disease. In the diagnosis, clinical features, i.e., signs, symptoms, laboratory features and mizaj (temperament) are important.
Any cause and or factor is countered by Quwwat-e-Mudabbira-e-Badan (the power of body responsible to maintain health), the failing of which may lead to quantitatively or qualitatively derangement of the normal equilibrium of akhlat (humors) of body which constitute the tissues and organs. This abnormal humor leads to pathological changes in the tissues anatomically and physiologically at the affected site and exhibits the clinical manifestations.
After diagnosing the disease, Usoole Ilaj (principle of management) of disease is determined on the basis of etiology in the following pattern:
- Izalae Sabab (elimination of cause)
- Tadeele Akhlat (normalization of humors)
- Tadeele Aza (normalization of tissues/organs)
For fulfillment of requirements of principle of management, treatment is decided as per the Unani medicine which may be one or more of the following:
- Ilaj-Bil-Tadbeer wa Ilaj-Bil-Ghiza (Regimenal Therapy). The disease may be treated by the modification of six essential pre-requisites of health (Asbab-e-Sitta Zarooriya in Unani Tibbi terminology). Asbab-e-Sitta Zarooriya may be modified by the use of one or more regimens: i.e., Dalak, Riyazat, Hammam, Taleeq, Takmeed, Hijamat (Cupping Therapy), Fasd, Lakhlakha, Bakhur, Abzan, Shamoomat (Aromatherapy), Pashoya, Idrar, Ishal, Qai, Tareeq, Elam, Laza-e-Muqabil, Imalah and alteration of food. According to the norms of C.C.I.M. New Delhi, Department of Ilaj-Bil-Tadbeer has been established in almost all Unani Tibbi Colleges of India. In the State Unani Medical College, Allahabad, U.P. and State Takmeel-Ul-Tibb College, Lucknow, Department of Ilaj-Bil-Tadbeer is known as Moalijat Khususi. Moaliajt Khususi is the old nomenclature of Ilaj-Bil-Tadbeer, suggested by C.C.I.M. New Delhi. Ilaj-Bil-Tadbeer is synonym to Panchkarma in Ayurveda.
- Ilaj-Bil-Advia (Pharmacotherapy). For this purpose Mamulate Matab Nuskha (prescription) is formulated which contain the single and or compound (murakkābāt) Unani drugs[12] having desired actions as per requirements.
- Ilaj-Bil-Yad (Surgery)
As an alternative form of medicine, Unani has found favor in India where popular products like Roghan Baiza Murgh (Egg Oil) and Roghan Badaam Shirin (Almond Oil) are commonly used for hair care. Unani practitioners can practice as qualified doctors in India, as the government approve their practice. Unani medicine is very close to Ayurveda. Both are based on theory of the presence of the elements (in Unani, they are considered to be fire, water, earth and air) in the human body. (The elements, attributed to the philosopher Empedocles, determined the way of thinking in Medieval Europe.) According to followers of Unani medicine, these elements are present in different fluids and their balance leads to health and their imbalance leads to illness.
The theory postulates the presence of blood, phlegm, yellow bile and black bile in the human body. Each person’s unique mixture of these substances determines his Mizaj(Temperament). a predominance of blood gives a sanguine temperament; a predominance of phlegm makes one phlegmatic; yellow bile, bilious (or choleric); and black bile, melancholic.
Education and recognition
In India, there are 40 Unani medical colleges where the Unani system of medicine is taught. After five and half year courses, the graduates are awarded BUMS (Bachelor of Unani Medicine and Surgery). There are about eight Unani medical colleges where a postgraduate degree (Mahir-e-Tib and Mahir Jarahat) is being awarded to BUMS doctors. All these colleges are affiliated to reputed universities and recognized by the governments.
In India, the Central Council of Indian Medicine (CCIM) a statutory body established in 1971 under Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), Ministry of Health and Family Welfare, Government of India, monitors higher education in areas of Indian medicine including, Ayurveda, Unani and Siddha. To fight biopiracy and unethical patents, the Government of India, in 2001, set up the Traditional Knowledge Digital Library as repository of formulations of systems of Indian medicine, includes 98,700 Unani formulations.[14][15] Central Council for Research in Unani Medicine (CCRUM) established in 1979, also under AYUSH, aids and co-ordinates scientific research in the Unani system of medicine through a network of 22 nationwide research institutes and units, including two Central Research Institutes of Unani Medicine, at Hyderabad and Lucknow, eight Regional Research Institutes at Chennai, Bhadrak, Patna, Aligarh, Mumbai, Srinagar, Kolkata and New Delhi, six Clinical Research Units at Allahabad, Bangalore, Karimganj, Meerut, Bhopal and Burhanpur, four Drug Standardisation Research Units at New Delhi, Bangalore, Chennai and Lucknow, a Chemical Research Unit at Aligarh, a Literary Research Institute at New Delhi.
Safety issues
According to WHO, “Pharmacovigilance activities are done to monitor detection, assessment, understanding and prevention of any obnoxious adverse reactions to drugs at therapeutic concentration that is used or is intended to be used to modify or explore physiological system or pathological states for the benefit of recipient.” These drugs may be any substance or product including herbs, minerals, etc. for animals and human beings and can even be that prescribed by practitioners of Unani or ayurvedic system of medicine. In recent days, awareness has been created related to safety and adverse drug reaction monitoring of herbal drugs including Unani drugs.
Notable Unani Organizations/institutions
- GOVERNMENT UNANI MEDICAL COLLEGE,CHENNAI, TAMILNADU
JAMIA TIBBIYA DEOBAND (B.U.M.S. & M.D.)
- SHAMIM AHMAD SAEEDI UNANI HOSPITAL FOR JOINTS PAIN
- JAMIA REMEDIES (UNANI DRUGS MANUFACTURING COMPANY, INDIA)
- Baqai Dawakhana pvt ltd,Delhi India
- Awami Laboratories, Lahore, Pakistan
- Hamdard University, Karachi, Pakistan
- Farzana Dawakhana, Karachi, Pakistan
- Central Council for Research in Unani Medicine,India.
- Ajmal Khan Tibbia College, Aligarh Muslim University, Aligarh,U.P.India.
- Ibn Sina Academy of Medieval Medicine and Sciences,India.
- National Institute of Unani Medicine, (Government of India)
- A&U Tibbia College, Karol Bagh, New Delhi, (Government of N.C.T. Delhi),India.
- Faculty of Unani Medicine, Jamia Hamdard, New Delhi,India.
- Government Nizamia Tibbi College and Hospital, Hyderabad, A.P.India.
- Anjuman-i- Islam’s Tibbia College and Hospital, Mumbai, Maharashtra, India.
- ZVM Unani College and Hospital, Pune, M.S.India.
- State Takmeel-ut-tib College and hospital, Lucknow, U.P.(Government of U.P.).India.
- State Unani Medical College & H.A.H.R.D.M. Hospital, Himmatganj, Allahabad, U.P. (Government of U.P.).India.
- Saifia Hamidia Unani Tibbia College & Saeeda Hospital, Ganpati Naka, Burhanpur,M.P.India.
- Tipu Sultan Unani Medical College,Gulbarga, Karnataka.
- Govt. Unani and Ayurvedic Medical College & Hospital, Dhaka, Bangladesh
- Markaz Unani Medical College & Hospital, Calicut, India
- The Institute of Indigenous Medicine, University of Colombo, Sri Lanka
- Government Unani Medical College, Bashaveshwara Nagar, Bangalore-560079
- Mohsin-e-millat Unani Medical College and Hospital (Baijnathpara Raipur,chhattisgarh India)
- HSZH Govt. Unani medical college Bhopal-462003
- Ahmed Garib Unani Medical College Akkalkuwa Nandurbar M.S India
- All India Unani Tibbi Conference, New Delhi.
- Awami Dawakhana Unani,Hyderabad,India.
- Govt.Nizamia Tibbi College, Hyderabad,India.
New Drug Approvals 