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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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Biosimilars: 10 Drugs to Watch


Genetic Engineering & Biotechnology News | www.genengnews.com

Biotechnology from bench to business

Biosimilars: 10 Drugs to Watch

Which innovator drugs are companies scrambling to copy?

read at

http://www.genengnews.com/insight-and-intelligence/biosimilars-10-drugs-to-watch/77899804/

http://www.genengnews.com/insight-and-intelligence

 

have a great reading

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Researchers at Northeastern University in Boston have developed a gene therapy approach that may one day stop Parkinson’s disease (PD) in it tracks, preventing disease progression and reversing its symptoms


Glial cell derived neurotrophic factor structure (credit: Wikimedia Commons)

http://experimentalbiology.org/EB/pages/default.aspx?splashpage=1

A noninvasive avenue for Parkinson’s disease gene therapy

Nanoparticles bypass the blood-brain barrier to treat Parkinson’s disease
April 26, 2013

Researchers at Northeastern University in Boston have developed a gene therapy approach that may one day stop Parkinson’s disease (PD) in it tracks, preventing disease progression and reversing its symptoms.

The novelty of the approach lies in the nasal route of administration and nanoparticles containing a gene capable of rescuing dying neurons in the brain.


Parkinson’s is a devastating neurodegenerative disorder caused by the death of dopamine neurons in a key motor area of the brain, the substantia nigra (SN). Loss of these neurons leads to the characteristic tremor and slowed movements of PD, which get increasingly worse with time.

Currently, more than 1% of the population over age 60 has PD and approximately 60,000 Americans are newly diagnosed every year. The available drugs on the market for PD mimic or replace the lost dopamine but do not get to the heart of the problem, which is the progressive loss of the dopamine neurons.


The focus of Dr. Barbara Waszczak‘s lab at Northeastern University in Boston is to find a way to harvest the potential of glial cell line-derived neurotrophic factor (GDNF) as a treatment for PD. GDNF is a protein known to nourish dopamine neurons by activating survival and growth-promoting pathways inside the cells.

Bypassing the blood-brain barrier

Not surprisingly, GDNF is able to protect dopamine neurons from injury and restore the function of damaged and dying neurons in many animal models of PD. However, the action of GDNF is limited by its inability to cross the blood-brain barrier (BBB), thus requiring direct surgical injection into the brain.

To circumvent this problem, Waszczak’s lab is investigating intranasal delivery as a way to bypass the BBB. Their previous work showed that intranasal delivery of GDNF protects dopamine neurons from damage by the neurotoxin, 6-hydroxydopamine (6-OHDA), a standard rat model of PD.

Taking this work a step further, Brendan Harmon, working in Waszczak’s lab, has adapted the intranasal approach so that cells in the brain can continuously produce GDNF. His work utilized nanoparticles, developed by Copernicus Therapeutics, Inc., which are able to transfect brain cells with an expression plasmid carrying the gene for GDNF (pGDNF).

When given intranasally to rats, these pGDNF nanoparticles increase GDNF production throughout the brain for long periods, avoiding the need for frequent re-dosing.

Now, in new research presented at Experimental Biology 2013 in Boston, Harmon reported that intranasal administration of Copernicus’ pGDNF nanoparticles results in GDNF expression sufficient to protect SN dopamine neurons in the 6-OHDA model of PD.

Waszczak and Harmon believe that intranasal delivery of Copernicus’ nanoparticles may provide an effective and non-invasive means of GDNF gene therapy for PD, and an avenue for transporting other gene therapy vectors to the brain.

This work, which was funded in part by the Michael J. Fox Foundation for Parkinson’s Research and Northeastern University, has the potential to greatly expand treatment options for PD and many other central nervous system disorders.

Potential diabetes breakthrough Harvard researchers discover hormone that spurs beta cell production


betatrophin_cell

Betatrophin causes a specific increase in pancreatic β cell replication. Betatrophin is a secreted protein expressed in liver and fat. The increase in β cell replication and mass improves glycemic control. (Credit: Peng Yi, Ji-Sun Park, Douglas A. Melton/Cell)

Potential diabetes breakthrough

Harvard researchers discover hormone that spurs beta cell production

Researchers at the Harvard Stem Cell Institute (HSCI) have discovered a hormone that holds promise for a dramatically more effective treatment of type 2 diabetes, a metabolic illness afflicting an estimated 26 million Americans.

The researchers believe that the hormone might also have a role in treating type 1, or juvenile, diabetes.

The work was published by the journal Cell.

The hormone, called betatrophin, causes mice to produce insulin-secreting pancreatic beta cells at up to 30 times the normal rate. The new beta cells only produce insulin when called for by the body, offering the potential for the natural regulation of insulin and a great reduction in the complications associated with diabetes, the leading medical cause of amputations and non-genetic loss of vision.

The researchers who discovered betatrophin, HSCI co-director Doug Melton and postdoctoral fellow Peng Yi, caution that much work remains to be done before it could be used as a treatment in humans. But the results of their work, which was supported in large part by a federal research grant, already have attracted the attention of drug manufacturers.

“If this could be used in people,” said Melton, Harvard’s Xander University Professor and co-chair of the University’s Department of Stem Cell and Regenerative Biology, “it could eventually mean that instead of taking insulin injections three times a day, you might take an injection of this hormone once a week or once a month, or in the best case maybe even once a year.”

Type 2 diabetes, a disease associated with the national obesity epidemic, is usually caused by a combination of excess weight and lack of exercise. It causes patients to slowly lose beta cells and the ability to produce adequate insulin. One recent study has estimated that diabetes treatment and complications cost the United States $218 billion annually, or about 10 percent of the nation’s entire health bill.

“Our idea here is relatively simple,” Melton said. “We would provide this hormone, the type 2 diabetic will make more of their own insulin-producing cells, and this will slow down, if not stop, the progression of their diabetes. I’ve never seen any treatment that causes such an enormous leap in beta cell replication.”

CHINA MARKET-Takeda and Sanofi Sign Co-promotion Agreement to Expand Reach of Diabetes Treatment Alogliptin in China


ALOGLIPTIN

22.04.2013

• Alogliptin is a DPP-4 inhibitor that is designed to slow the inactivation of incretin hormones GLP-1 and GIP
• Agreement is part of Takeda’s strategy to complement capabilities through partnerships
• Agreement complements Sanofi’s diabetes portfolio and expand its offer of innovative diabetes treatment to Chinese patients
• The regulatory approval of alogliptin in China is expected in 2013

Shanghai, China, April 22, 2013 – Takeda and Sanofi today announced that they have entered into an agreement for the co-promotion of alogliptin in China for the treatment of type 2 diabetes. Alogliptin is Takeda’s new type 2 diabetes therapy, which has been filed for marketing authorization in China. It is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).

Under the terms of the agreement, Takeda will grant Sanofi the exclusive right to co-promote alogliptin in China. Sanofi will utilize its commercial capabilities and experience to promote the product in defined territories in China. The commercial terms of the agreement were not disclosed.

“Diabetes has become a major public health problem in China with a rapid increase in the prevalence over recent years. China is now the country with the largest number of people with diabetes,” said Haruhiko Hirate, Corporate Officer and Head of North Asia of Takeda. “The collaboration will expand our reach to Chinese physicians treating patients with type 2 diabetes. Both Takeda and Sanofi have a long history and significant experience in diabetes and this makes for a win-win partnership, as we work together to advance patient care and help to meet the needs of this growing patient population.”

“We are pleased to announce the collaboration with Takeda,” said Fabrice Baschiera, General Manager, Pharmaceutical Operations, Sanofi China. “Alogliptin reinforces the strategic focus of Sanofi in the diabetes field. The new addition of alogliptin strengthens our offer of innovative diabetes treatment to Chinese patients, which includes best-in-class oral and insulin drugs. We look forward to working with Takeda to make alogliptin more widely available to patients with type 2 diabetes in China,” added Mr. Baschiera.

Alogliptin was approved and marketed in Japan in 2010 under the brand name of Nesina®, where it is currently the best-selling DPP-4i for type 2 diabetes. It was approved by the U.S. FDA as a monotherapy and also in fixed-dose combination with pioglitazone (Oseni®) and metformin (Kazano®) in January 2013 for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.

In China, the rapid economic development has brought mass urbanization, changing diets and increasingly sedentary lifestyles. These factors greatly increase the risk of developing type 2 diabetes. China has the largest number of people with diabetes1, with approximately 92.4 million adults suffering from the disease, 60.7% of which are undiagnosed2. Over the next 20 years, an additional 40 million Chinese adults are expected to develop type 2 diabetes, surpassing the overall prevalence rate of the United States3.

Alogliptin is under registration review in China. Takeda is expecting to obtain the regulatory approval in 2013.

Notes
1 International Diabetes Federation. New diabetes figures in China: IDF press statement
2 Diabetes: Wenying Yang et al, N ENGL J MED, March 25, 2010;
3 Kantar Health. The Burden of the Complicated Type 2 Diabetes Patient in China.

About Alogliptin
Alogliptin is a DPP-4i for the treatment of type 2 diabetes as an adjunct to diet and exercise. DPP-4 is designed to slow the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. A New Drug Application (NDA) for NESINA (alogliptin) was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is available under the same brand name in Japan. NESINA (alogliptin) was approved by the U.S. FDA as a monotherapy and also in fixed-dose combination with pioglitazone (OSENI) and metformin (KAZANO) in January 2013 for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes affecting millions of people globally. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help them manage their blood glucose levels. According to the International Diabetes Federation, the global health care expenditures for diabetes (both type 1 and 2) were estimated at $471.6 billion in 2012. By 2030, this number is projected to exceed $595 billion. China is now the country with the largest number of people with diabetes and 92.4 million adults are suffering from the disease.

About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website,www.takeda.com.

About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

http://www.tpi.takeda.com/media/news-releases/2013/takeda-and-sanofi-sign-co-promotion-agreement-to-expand-reach-of–alogliptin/

 

From a structural point has uracil (Uracil) structure, synthesis of these compounds are usually replaced with urea or urea and 1,3 – parents Electric reagent directly related ring, and substituted ureas from amines and isocyanate obtained. Compound 1 and methyl isocyanate urea derivatives obtained by reacting 2 , 2 and 1,3 – diethyl reaction 3 , 3 chlorination with phosphorus oxychloride to obtain 4 , 4 with a secondary amine 5 reaction of 6 , 6 de-Boc protected with acid reaction and generate benzoate Alogliptin benzoate.

EMA- Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Spedra, for the treatment of erectile dysfunction in adult men.


AVANAFIL, SPEDRA

On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Spedra, 50 mg, 100 mg, 200 mg, tablet intended for the treatment of erectile dysfunction in adult men.

The applicant for this medicinal product is VIVUS BV.

They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion. The active substance of Spedra is avanafil, a selective phosphodiesterase (PDE) type 5 inhibitor that leads to higher cyclic guanosine monophosphate (cGMP)-specific PDE5 levels. This enhances smooth muscle relaxation, which results in an inflow of blood into the penile tissues, thereby producing an erection. The benefit with Spedra is its effect on the ability of men with erectile dysfunction to achieve and maintain an erection sufficient for satisfactory sexual activity. It was observed in clinical trials that Spedra increased the percentage of sexual attempts resulting in successful intercourse by roughly 20-30% over placebo in the general population of adult men with erectile dysfunction. The most common side effects are headache, flushing, nasal and sinus congestion, dyspepsia and back pain. A pharmacovigilance plan for Spedra will be implemented as part of the marketing authorisation. The approved indication is: “Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.” Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission. The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Spedra and therefore recommends the granting of the marketing authorisation.

Avanafil is a PDE5 inhibitor approved for erectile dysfunction on April 27, 2012.[1] Avanafil is known by the trademark name Stendra and was developed by Vivus Inc. It acts by inhibiting a specific phosphodiesterase type 5 enzyme which is found in various body tissues, but primarily in the corpus cavernosum penis, as well as the retina. Other similar drugs are sildenafil, tadalafil and vardenafil. The advantage of avanafil is that it has very fast onset of action compared with other PDE5 inhibitors.

Avanafil can be synthesized from a benzylamine derivative and a pyrimidine derivative:

Avanafil synthesis.png

“FDA approves Stendra for erectile dysfunction” (Press release). Food and Drug Administration (FDA). April 27, 2012.

Yamada, K.; Matsuki, K.; Omori, K.; Kikkawa, K.; 2004, U.S. Patent 6,797,709

 

A cutting that phenanthrene by a methylthio urea ( a ) and ethoxy methylene malonate ( 2 ) cyclization of 3 , chloride, phosphorus oxychloride get 4 , 4 with benzyl amine 5 occurred SNAr the reaction product after oxidation with mCPBA 6 . In pyrimidine, if the 2 – and 4 – positions are active simultaneously the same leaving group in the case, SNAr reaction occurs preferentially at 4 – position, but does not guarantee the 2 – side reaction does not occur. Here is an activity of the poor leaving group sulfide spans 2 – bit, and a good leaving group active chlorine occupy four – position, thus ensuring a high regioselectivity of the reaction. 4 – position after completion of the reaction, then the 2 – position of the group activation, where sulfide sulfoxide better than the leaving group. Amino alcohols 7 and 6 recurrence SNAr reaction 8 , 8 after alkaline hydrolysis and acid alpha amidation get that phenanthrene.
A cutting that phenanthrene (Avanafil) -2012 April FDA-approved treatment for ED medication

European Medicines Agency recommends approval of first treatment for pseudobulbar affect


26/04/2013

Dextromethorphan

Quinidine

European Medicines Agency recommends approval of first treatment for pseudobulbar affect

Medicine to help curb bouts of uncontrolled emotional expression in patients with certain neurological disorders

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Nuedexta, a medicine for the treatment of pseudobulbar affect in adults.

Pseudobulbar affect is a medical condition in which patients experience sudden and uncontrollable bouts of laughing or crying unrelated or disproportionate to their emotional state. It occurs when certain neurological disorders, such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) or a stroke, damage areas of the brain that are involved in the control of normal expression of emotion. This damage can disrupt brain signalling, resulting in the alteration or loss of control of emotional expression.

Although pseudobulbar affect is a non-life-threatening condition, it can have a significant impact on an individual’s ability to interact normally in society and on their relationships with others. There is currently no treatment approved for pseudobulbar affect in the European Union.

Nuedexta is a combination of two known active substances, dextromethorphan hydrobromide and quinidine sulphate. In studies, treatment with these medicines significantly decreased episodes of involuntary, uncontrollable laughing or crying.

Pseudobulbar affect is observed in a number of neurological conditions. Nuedexta has currently only been studied in patients with MS and ALS. Nuedexta is not suitable for treating episodes of laughing or crying brought on by mood swings and not due to pseudobulbar affect.

The CHMP’s opinion on Nuedexta will now be sent to the European Commission for the adoption of a marketing authorisation.

Note

  • The marketing authorisation holder for Nuedexta is Jenson Pharmaceutical Services Ltd.

Dextromethorphan/quinidine (trade name Nuedexta) is a combination drug containing the active ingredients dextromethorphan and quinidine. It was the first FDA-approved drug for the treatment of pseudobulbar affect (PBA).

In a 12 week randomized, double-blind trial, amyotrophic lateral sclerosis and multiple sclerosis patients with significant PBA were given either Nudexta 30/10 mg or placebo. In 326 randomized patients, the PBA-episode daily rate was 46.9% (p < 0.0001) lower for Nudexta than for placebo.

Nuedexta was approved in February 2011 and is marketed in the United States by Avanir Pharmaceuticals.

Celgene makes good start to 2013 as Revlimid hits $1 billion


April 26, 2013

Celgene makes good start to 2013 as Revlimid hits $1 billion

Celgene Corp has posted a healthy set of financials for the first quarter despite a 4.1% decline in net income to $410.2 million, as product sales increased 15% to $1.43 billion.  read more at————http://www.pharmatimes.com/Article/13-04-26/Celgene_makes_good_start_to_2013_as_Revlimid_hits_1_billion.aspx

File:Lenalidomide.png

(RS)-3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol- 2-yl)piperidine-2,6-dione

Lenalidomide

REVLIMID® is an oral immunomodulatory drug marketed in the United States and many international markets, in combination with dexamethasone, for treatment of patients with multiple myeloma who have received at least one prior therapy. It is also marketed in the United States and certain international markets for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes, or MDS, associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalitie.Revlimid Worldwide annual sales in 2011 was $3.2bLenalidomide (Revlimid) is a derivative of thalidomideintroduced in 2004.It was initially intended as a treatment for multiple myeloma, for which thalidomide is an accepted therapeutic treatment. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS). Lenalidomide has significantly improved overall survival in myeloma (which generally carries a poor prognosis), although toxicity remains an issue for users. [1]It costs $163,381 per year for the average patient.[2]

Lenalidomide has been used to successfully treat both inflammatory disorders and cancers in the past 10 years. There are multiple mechanisms of action, and they can be simplified by organizing them as mechanisms of action in vitro and in vivo.[3] In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of the microenvironment support for tumor cells, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory activity. Lenalidomide has a broad range of activities that can be exploited to treat many hematologic and solid cancers.

  1. McCarthy; Philip L. McCarthy, Kouros Owzar, Craig C. Hofmeister, et al. (May 10, 2012). “Lenalidomide after Stem-Cell Transplantation for Multiple Myeloma”N Engl J Med 366 (19): 1770–1781. doi:10.1056/NEJMoa1114083PMID 22571201.
  2. Badros, Ashraf Z. Badros (May 10, 2012). “Lenalidomide in Myeloma — A High-Maintenance Friend”N Engl J Med 366 (19): 1836–1838. doi:10.1056/NEJMe1202819PMID 22571206.
  3. Vallet S, Palumbo A, Raje N, Boccadoro M, Anderson KC (July 2008). “Thalidomide and lenalidomide: Mechanism-based potential drug combinations”. Leukemia & Lymphoma 49 (7): 1238–45. doi:10.1080/10428190802005191PMID 18452080.

Shire move delays Intuniv generic until 2014


Guanfacine (brand name Tenex, and the extended release Intuniv) is a sympatholytic. It is a selective α2A receptor agonist. These receptors are concentrated heavily in the prefrontal cortex and the locus coeruleus, with the potential to improve attention abilities via modulating post-synaptic α2A receptors in the prefrontal cortex. Guanfacine lowers both systolic and diastolic blood pressure by activating the central nervous system α2A norepinephrine autoreceptors, which results in reduced peripheral sympathetic outflow and thus a reduction in peripheral sympathetic tone. Its side-effects are dose dependent, with practically no dryness of the mouth at doses of 2 mg and less

April 26, 2013

 

Shire move delays Intuniv generic until 2014

 

Shire has come to an agreement with drugmakers Actavis and Watson that lays to rest all pending litigation over their attempts to launch a generic form of the attention-deficit hyperactivity drug (ADHD) Intuniv (guanfacine hydrochloride) in the US.

Under the settlement, Shire has granted Actavis a license to make and market its version of Intuniv in the US from December 1 next year, in return for a 25% royalty on gross profit during the 180 day period of exclusivity.

read more at—–http://www.pharmatimes.com/Article/13-04-26/Shire_move_delays_Intuniv_generic_until_2014.aspx

 

TOXINS-Occurrence of ochratoxin A in Korean paprika


New Drug Approvals

ochratoxin A

Occurrence of ochratoxin A in Korean red paprika

http://www.ncbi.nlm.nih.gov/pubmed/23605491

Mycotoxin Res. 2010 Nov;26(4):279-86. doi: 10.1007/s12550-010-0067-2. Epub 2010 Aug 26.

National Agricultural Products Quality Management Service, Seoul, 150-804, Korea, ahnjs@naqs.go.kr.

A large amount-260,000 tons-of red paprika is consumed annually in Korea, where the people prefer hot and pungent to sweet foods.

,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,

Mycotoxin Res. 1993 Sep;9(2):94-8. doi: 10.1007/BF03192240.

Occurrence of ochratoxin A in herbal drugs of Indian origin – a report.

Source

Medicinal Plant Research Laboratory, University Department of Botany, Bhagalpur University, 812 007, Bhagalpur, India.

Abstract

This paper contains a report of occurrence of ochratoxin A in some common herbal medicines collected from different store-houses and shop-keepers of Bihar, India. Of 129 samples of 9 plants, 55 were found to be contaminated with various levels of ochratoxin A. The level of ochratoxin A was found maximal in barks ofHolarrhena antidysenterica (1.14…

View original post 190 more words

TOXINS-Occurrence of ochratoxin A in herbal drugs of Indian origin – a report.


ochratoxin A

Occurrence of ochratoxin A in Korean red paprika

http://www.ncbi.nlm.nih.gov/pubmed/23605491

Mycotoxin Res. 2010 Nov;26(4):279-86. doi: 10.1007/s12550-010-0067-2. Epub 2010 Aug 26.

National Agricultural Products Quality Management Service, Seoul, 150-804, Korea, ahnjs@naqs.go.kr.

A large amount-260,000 tons-of red paprika is consumed annually in Korea, where the people prefer hot and pungent to sweet foods.

,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,

Mycotoxin Res. 1993 Sep;9(2):94-8. doi: 10.1007/BF03192240.

Occurrence of ochratoxin A in herbal drugs of Indian origin – a report.

Source

Medicinal Plant Research Laboratory, University Department of Botany, Bhagalpur University, 812 007, Bhagalpur, India.

Abstract

This paper contains a report of occurrence of ochratoxin A in some common herbal medicines collected from different store-houses and shop-keepers of Bihar, India. Of 129 samples of 9 plants, 55 were found to be contaminated with various levels of ochratoxin A. The level of ochratoxin A was found maximal in barks ofHolarrhena antidysenterica (1.14 – 2.34 μg/g) whereas it was minimal in rhizomes ofTacca aspera (0.3 – 0.74 μg/g).Aspergillus ochraceus, A sulphureus and Penicillium viridicatum isolates obtained from drug samples were also examined for their toxigenic potentials. 19 isolates ofA ochraceus, 13 ofA sulphureus and 37 isolates ofP viridicatum were found to be toxigenic out of 67, 33, and 107 isolates, respectively. The ochratoxin A produced by Aochraceus was in the range of 0.09 to 2.44 μg/mL, byA sulphureus 0.1 to 1.76 μg/mL, and byP viridicatum 0.14 to 2.78 μg/mL of the culture filtrate.

Ochratoxin A, a toxin produced by Aspergillus ochraceus, Aspergillus carbonarius and Penicillium verrucosum, is one of the most abundant food-contaminating mycotoxins.It is also a frequent contaminant of water-damaged houses and of heating ducts.Human exposure can occur through consumption of contaminated food products, particularly contaminated grain and pork products, as well as coffee, wine grapes and dried grapes.[4][5][6] The toxin has been found in the tissues and organs of animals, including human blood and breast milk. Ochratoxin A, like most toxic substances, has large species- and sex-specific toxicological differences.

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