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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Mafenide Acetate Topical Solution 5% Approved: February 12, 2013 – Par Pharmaceutical, Inc. Sulfamylon
Mafenide acetate, USP is a synthetic antimicrobial agent designated chemically as a-amino-p- toluenesulfonamide monoacetate. It has the following structural formula:
 |
C7H10N2O2S • C2H4O2
M.W. 246.29Mafenide acetate, USP is a white, crystalline powder which is freely soluble in water.
SULFAMYLON® (mafenide acetate) For 5% Topical Solution is provided in packets containing 50 g of sterile mafenide acetate to be reconstituted in 1000 mL of Sterile Water for irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. After mixing, the solution contains 5% w/v of mafenide acetate. The solution is an antimicrobial preparation suitable for topical administration. The solution Is not for Injection. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20° to 25°C (68° to 77°F). Limited storage periods at 15° to 30°C (59° to 86°F) are acceptable.
- Mafenide Acetate Topical Solution 5%
Approved: February 12, 2013 – Par Pharmaceutical, Inc.
Generic for: Sulfamylon
FDA grants fresh approval for Novartis’ Zortress, Everolimus
dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone
Everolimus (RAD-001) is the 40-O-(2-hydroxyethyl) derivative of sirolimus and works similarly to sirolimus as an inhibitor of mammalian target of rapamycin (mTOR).
It is currently used as an immunosuppressant to prevent rejection of organ transplants and treatment of renal cell cancer and other tumours. Much research has also been conducted on everolimus and other mTOR inhibitors for use in a number of cancers.
It is marketed by Novartis under the tradenames Zortress (USA) and Certican (Europe and other countries) in transplantation medicine, and Afinitor in oncology.
18 feb 2013
The US Food and Drug Administration has approved Novartis’ Zortress for preventing organ rejection in adults receiving a liver transplant.
The Swiss major noted that Zortress (everolimus) is the first mammalian target of rapamycin (mTOR) inhibitor given the green light for use following liver transplantation and the first immunosuppressant approved by the FDA in over a decade for that use. The treatment is already on the market for preventing organ rejection in kidney transplant patients.
The approval was based on the largest liver transplant study to date, conducted in 719 liver transplant patients, Novartis says. The data showed that Zortress plus reduced-exposure tacrolimus (a well-established immunosuppresant) led to comparable efficacy and higher renal function compared to standard tacrolimus at 12 months.
Novartis Pharma chief David Epstein noted that this second indication for Zortress in just three years in the USA follows the recent European approval (in the fourth quarter of 2012) of the drug for liver transplants. It is marketed there as Certican and is also approved in Europe in kidney and heart transplantation.
Everolimus is also sold as Afinitor and Volubia in various oncology indications and is licensed to Abbott Laboratories (and sublicensed to Boston Scientific) for use in drug-eluting stents.
http://www.nature.com/nrd/journal/v8/n7/full/nrd2924.html
take a tour
Eritrea, africa
Eritrea – Wikipedia, the free encyclopedia
Eritrea (/ˌɛrɨˈtreɪ.ə/ or /ˌɛrɨˈtriːə/; Tigrinya: ኤርትራ ʾErtrā ; Arabic: إرتريا … Its name Eritrea is based on the Greek name for the Red Sea (Ἐρυθρὰ …
Isaias AfwerkiIsaias Afwerki (sometimes spelled Afewerki; Tigrinya: ኢሳይያስ …
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History of EritreaHistory of Eritrea. Coat of Arms of Eritrea. Pre-colonial. Kingdom …
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asmara
asmara
Massawa Old City
Eritrea – Island of the Red Seo of Eritrea –
keren
“Asara” traditional sesami oil press – Eritrea (Saied Ibrahim Yehdego)
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Nanyang Technological University, Singapore, prepares for trial of glaucoma drug
If glaucoma is left untreated, it can lead to blindness.–Courtesy of NIH
LipoLat, a controlled-release glaucoma therapeutic, is a suspension of nanocapsules each trapping a payload of drug. Designed as an injection into the conjunctiva (the outer layer of the eye), LipoLat gradually released the drug and was as effective as eye drops for as long as three months in preclinical trials. According to the researchers, this is now ready to move into human studies.
12th feb 2013
preclinical trials
http://media.ntu.edu.sg/NewsReleases/Pages/newsdetail.aspx?news=15fdbb3e-6724-4bc9-a699-a486c25f510e
For glaucoma patients, taking daily medication will soon become a thing of the past. With Nanyang Technological University’s (NTU) newest solution, a simple, quick and painless injection four times a year would be enough. The solution contains an anti-glaucoma drug wrapped in nano-sized capsules, and is delivered by an injection into the outer layer in the front of the eye (conjunctiva) by the doctor.
The nanocarrier will then slowly release the drug over several weeks. LipoLat, as it is known, is now ready for clinical trials. Extensive pre-clinical studies have shown that this single injection is as effective at treating glaucoma as taking daily eye drops for up to three months.
The newly launched Ocular Therapeutic Engineering Centre will work on this research. Housed at NTU’s School of Materials Science and Engineering, the center builds upon the School’s successful research collaboration with the Singapore Eye Research Institute. The center’s director Professor Subbu Venkatraman, who is also the school chair, said the center will build on the strong research collaboration between clinical scientists and NTU technologists, to develop new drug delivery systems for the eye.
“I hope to showcase this as a good example of how close interactions between medical practitioners and technology providers can lead to rapid translation of ideas to the clinic, such as LipoLat,” said Prof Venkatraman. “We are confident that the products co-developed at the centre will lead on to further discoveries and innovations in ocular therapy.” Working closely with Prof Venkatraman as the co-director of the center is Dr Tina Wong, an adjunct associate professor at the School of Materials Science and Engineering and a senior consultant at the Singapore National Eye Centre. She is also head of the Ocular Therapeutics and Drug Delivery Research Group at the Singapore Eye Research Institute
.
Extensive pre-clinical studies have shown that a single injection of the solution developed by Nanyang Technological University is effective in treating glaucoma
The solution developed by the university contains an anti-glaucoma drug wrapped in nano-sized capsules
The solution developed by the university contains an anti-glaucoma drug wrapped in nano-sized capsules
Working closely with Prof Venkatraman (picture) as the Co-Director of the centre is Dr Tina Wong (picture)
Celgene gains SFDA China, approval for marketing Revlimid (lenalidomide) to treat multiple myeloma
(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]
Mechanism of action
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.
- 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/NEJMoa1114083. PMID 22571201.
- 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/NEJMe1202819. PMID 22571206.
- 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:10.1080/10428190802005191. PMID 18452080.
FDA approves first retinal implant for adults with rare genetic eye disease
Argus II (credit: Second Sight)Second Sight Medical Products, Inc., is the manufacturer and is already approved in Europe
Argus II components (credit: FDA)
The Argus II design consists of an external video camera system matched to the implanted retinal stimulator, which contains a microelectrode array that spans 20 degrees of visual field.
An external camera system, built into a pair of glasses, streams video to a belt-worn computer, which converts the video into stimulus commands for the implant.
The belt-worn video processing unit (computer) encodes the commands into a wireless signal that is transmitted to the implant, which has the necessary electronics to receive and decode both wireless power and data.
Artificial retina device, consisting of a glasses-mounted camera and a microchip surgically implanted on the retina
Based on those data, the implant stimulates the retina with small electrical pulses. The electronics are hermetically packaged and the electrical stimulus is delivered to the retina via a microelectrode array.
Peregrine Pharmaceuticals Announces Results From Phase II Clinical Trial of Bavituximab in Stage IV Pancreatic Cancer
TUSTIN, CA 02/13/13 — Peregrine Pharmaceuticals announced results from its 70 patient open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer. The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression. Results showed that the combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm). In the trial, patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 13% in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75).
Bavituximab binds to phosphatidylserine which is exposed on the surface of certain atypical animal cells, including tumour cells and cells infected with any of six different families of virus. These viral families contain the viruses hepatitis C, influenza A and B, HIV 1 and 2, measles, respiratory syncytial virus and pichinde virus, which is a model for the deadly Lassa virus.[2] Other cells are not affected since phosphatidylserine normally is only intracellular.[3]
Bavituximab binds to various aminophospholipids and is dependent on interaction with plasma protein beta-2 glycoprotein I to mediate binding.
These target aminophospholipids, usually residing only on the inner leaflet of the plasma membrane of cells, become exposed in virally infected, damaged or malignant cells, and more generally in most cells undergoing the process of apoptosis.
The antibody’s binding to phospholipids alerts the body’s immune system to attack the tumor endothelial cells, thrombosing the tumor’s vascular network and/or attacking free floating virally infected and metastatic cells while potentially minimizing side effects in healthy tissues.
- Statement on a nonproprietary name adopted by the USAN council
- Nature Medicine 14, 1357 – 1362 (2008)
- He, J.; Yin, Y.; Luster, T. A.; Watkins, L.; Thorpe, P. E. (2009). “Antiphosphatidylserine Antibody Combined with Irradiation Damages Tumor Blood Vessels and Induces Tumor Immunity in a Rat Model of Glioblastoma”. Clinical Cancer Research 15 (22): 6871–6880. doi:10.1158/1078-0432.CCR-09-1499. PMID 19887482. edit
- New Progression-Free Survival Data From Peregrine’s Bavituximab in Phase II Refractory Breast Cancer
- Phase II Advanced Breast Cancer Data to Be Presented at ASCO Highlight Promising Tumor Response and Progression-Free Survival Data With Peregrine’s Bavituximab
- Pharma company completes humanization of 3G4 antibody
- He, J.; Luster, T. A.; Thorpe, P. E. (2007). “Radiation-Enhanced Vascular Targeting of Human Lung Cancers in Mice with a Monoclonal Antibody That Binds Anionic Phospholipids”. Clinical Cancer Research 13 (17): 5211–5218. doi:10.1158/1078-0432.CCR-07-0793. PMID 17785577. edit
- Ran; Downes, A.; Thorpe, P. E. (2002). “Increased exposure of anionic phospholipids on the surface of tumor blood vessels”. Cancer Research 62 (21): 6132–6140. PMID 12414638.
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AbbVie Announces First Long-term, Patient-Reported Health Outcomes Data for Use of HUMIRA® (Adalimumab) in Patients with Pediatric Crohn’s Disease
Adalimumab
monoclonal antibody
http://www.nature.com/nrd/journal/v2/n9/fig_tab/nrd1182_F1.html
VIENNA, Feb. 15, 2013 AbbVie announced the first long-term, patient-reported health outcomes data from analyses of the Phase 3 IMAgINE-1 trial. The analyses assessed improvements in health-related quality of life (HRQOL) measures for pediatric patients aged 6 to 17 years with severe active Crohn’s disease, taking HUMIRA, who had an inadequate response, were intolerant or had contraindications to conventional therapy, as well as the work productivity of their caregivers throughout the 52-week study. The results of these analyses are being presented this week at the European Crohn’s and Colitis Organisation (ECCO) 8th Annual Congress.
Adalimumab (HUMIRA, Abbott) is the third TNF inhibitor, after infliximab and etanercept, to be approved in the United States. Like infliximab and etanercept, adalimumab binds to Tumor necrosis factor-alpha (TNFα), preventing it from activating TNF receptors. Adalimumab was constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimeric antibody and etanercept is a TNF receptor-IgG fusion protein. TNFα inactivation has proven to be important in downregulating the inflammatory reactions associated with autoimmune diseases. As of 2008 adalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. Although only approved for ulcerative colitis from late 2012 by the FDA in the disease’s management, it has been used for several years in cases that have not responded to conventional treatment at standard dosing for Crohn’s Disease.
However, because TNFα is part of the immune system that protects the body from infection, prolonged treatment with adalimumab may slightly increase the risk of developing infections.
HUMIRA (“Human Monoclonal Antibody in Rheumatoid Arthritis”) is marketed in both preloaded 0.8 mL syringes and also in preloaded pen devices (called Humira Pen), both injected subcutaneously, typically by the patient at home.
Adalimumab was discovered as a result of the collaboration between BASF Bioresearch Corporation (Worcester, Massachusetts, a unit of BASF) and Cambridge Antibody Technology which began in 1993.[4]
The drug candidate was discovered initially using CAT’s phage display technology and named D2E7.[2] The key components of the drug were found by guiding the selection of human antibodies from phage display repertoires to a single epitope of an antigen TNF alpha.[5] The ultimate clinical candidate, D2E7, was created and manufactured at BASF Bioresearch Corporation and taken through most of the drug development process by BASF Knoll, then further development, manufacturing and marketing by Abbott Laboratories, after Abbott acquired the pharmaceutical arm of BASF Knoll.[6]
Adalimumab was the first fully human monoclonal antibody drug approved by the FDA. It was derived from phage display,[1] and was discovered through a collaboration between BASF Bioresearch Corporation (Worcester, Massachusetts, a unit of BASF) and Cambridge Antibody Technology as D2E7,[2] then further manufactured at BASF Bioresearch Corporation and developed by BASF Knoll (BASF Pharma) and, ultimately, manufactured and marketed by Abbott Laboratories after the acquisition of BASF Pharma by Abbott.
In 2009, HUMIRA had over $5 billion in annual sales.[3]
Components of a Humira autoinjector pen
- Brekke OH , Sandlie I (January 2003). “Therapeutic antibodies for human diseases at the dawn of the twenty-first century”. Nat Rev Drug Discov 2 (1): 52–62. doi:10.1038/nrd984. PMID 12509759.
- Kempeni J (January 1999). “Preliminary results of early clinical trials with the fully human anti-TNFα monoclonal antibody D2E7”. Ann Rheum Dis 58 (suppl 1): I70–2. doi:10.1136/ard.58.2008.i70. PMC 1766582. PMID 10577977.
- http://www.abbott.com/static/content/microsite/annual_report/2006/humira.html
- [1] Cambridge Antibody Technology website
- Jespers LS, Roberts A, Mahler SM, Winter G, Hoogenboom HR (September 1994). “Guiding the selection of human antibodies from phage display repertoires to a single epitope of an antigen”. Biotechnology (N.Y.) 12 (9): 899–903. doi:10.1038/nbt0994-899. PMID 7521646.
- http://www2.basf.us/corporate/news2000/newsknoll_pharma_121500.html
- http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/11-12-2001/0001613559&EDATE=
- Rau R (January 2002). “Adalimumab (a fully human anti-tumour necrosis factor α monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials”. Ann Rheum Dis 61 (Suppl 2): ii70–3. doi:10.1136/ard.61.suppl_2.ii70. PMC 1766697. PMID 12379628.
Genzyme Announces Positive New Data from Two Phase 3 Studies for Oral Eliglustat Tartrate for Gaucher Disease
Eliglustat tartrate (USAN)
ENGAGE Study Results:
In ENGAGE, a Phase 3 trial to evaluate the safety and efficacy of eliglustat tartrate in 40 treatment-naïve patients with Gaucher disease type 1, improvements were observed across all primary and secondary efficacy endpoints over the 9-month study period. Results were reported today at the WORLD Symposium by Pramod Mistry, MD, PhD, FRCP, Professor of Pediatrics & Internal Medicine at Yale University School of Medicine, and an investigator in the trial.
The randomized, double-blind, placebo-controlled study had a primary efficacy endpoint of improvement in spleen size in patients treated with eliglustat tartrate. Patients were stratified at baseline by spleen volume. In the study, a statistically significant improvement in spleen size was observed at nine months in patients treated with eliglustat tartrate compared with placebo. Spleen volume in patients treated with eliglustat tartrate decreased from baseline by a mean of 28 percent compared with a mean increase of two percent in placebo patients, for an absolute difference of 30 percent (p<0.0001).
Eliglustat tartate (Genz-112638)
What is Eliglustat?
- Eliglustat is a new investigational phase 3 compound from Genzyme Corporation that is being studied for type 1 Gaucher Disease.
- Eliglustat works as a substrate reduction therapy by reducing glucocerebroside. formation.
- This product is an oral agent (i.e. a pill) that is taken once or twice a day in contrast to an IV infusion for enzyme replacement therapy. Enzyme replacement therapy focuses on replenishing the enzyme that is deficient in Gaucher Disease and breaks down glucocerebroside that accumulates.
- The clinical trials for eliglustat tartate are sponsored by Genzyme Corporation.
BioAlliance Pharma announces the forthcoming extension of its phase II clinical trial with Validive® in the United States
CLONIDINE
FEB14 2013
BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces the extension of its phase II clinical trial with Validive® (clonidine Lauriad™) in the United States in radio/chemotherapy-induced oral mucositis prevention in patients with head and neck cancer.
Further to approval by the United States FDA (Food and Drug Administration), BioAlliance Pharma will extend its clinical trial to the United States, increasing the number of clinical investigation centers involved in this randomized double blind phase II trial.
So far almost 50% of planned patients have been enrolled in about 30 European centers. With the upcoming initiation of several centers in the United States, BioAlliance Pharma expects to finalize trial recruitment in early 2014 with results expected the same year.
“Beyond accelerating recruitment, the extension of the trial to the United States is also a key factor to reinforce our international panel of scientific experts and clinical investigators around Validive®. This will raise awareness and create hands-on experience of the drug of future key prescribers of Validive® in major US centers specialized in oncology and radiotherapy,” stated Judith Greciet, CEO of BioAlliance Pharma.
Severe oral mucositis is a particularly invalidating pathology occurring in more than 60% of patients treated with radio/chemotherapy for head and neck cancer and has currently no validated curative or preventive treatment. It may induce intense oral pain and eating disability requiring enteral or parenteral nutritional support. Thirty per cent of patients need to be hospitalized as a result and symptoms can force patients to stop treatment for an undefined period thus reducing treatment efficacy.
Clonidine is a sympatholytic medication used to treat medical conditions, such as high blood pressure, ADHD, anxiety/panic disorder, and certain pain conditions. It is classified as a centrally acting α2 adrenergic agonist. An alternative hypothesis that has been proposed is that clonidine acts centrally as an imidazoline receptor agonist.
Synthesis
Clonidine, 2-(2,6-dichlorophenylamino)imidazoline, is synthesized from 2,6-dichloroaniline, the reaction of which with ammonium thiocyanate gives N-(2,6- dichlorophenyl)thiourea. Methylation of this product, followed by the subsequent reaction with ethylene diamine gives clonidine. 
- K. Zeile, H. Staehle, K. H. Hauotman, DE 1303141 (1961).
- H. Stahle, K. Zeile, U.S. Patent 3,202,660 (1965).
- K. Zeile, K. H. Hauotman, H. Stahle, U.S. Patent 3,236,857 (1966).
- Boehringer Sohn Ingelheim, BE 653933 (1964).
- Boehringer Sohn Ingelheim, GB 1016514 (1962).
- Boehringer Ingelheim GmbH, GB 1034938 (1964).
US patent 3937717, Stahle, H.; Koppe, H.; Kummer, W.; Stockhaus, K., “2-Phenylamino-imidazolines-(2)”, issued 1976-02-10, assigned to Boehringer Ingelheim GmbH
CLORPRES (clonidine hydrochloride and chlorthalidone) ® is a combination of clonidine hydrochloride (a centrally acting antihypertensive agent) and chlorthalidone (a diuretic).
CLORPRES (clonidine hydrochloride and chlorthalidone) ® is available as tablets for oral administration in three dosage strengths: 0.1 mg/15 mg, 0.2 mg/15 mg and 0.3 mg/15 mg of clonidine hydrochloride/chlorthalidone, respectively.
The inactive ingredients are ammonium chloride, colloidal silicon dioxide, croscarmellose sodium (Type A), magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, D&C yellow #10.
Clonidine Hydrochloride
Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-[(2,6-dichlorophenyl)imino]imidazoline monohydrochloride. The following are the structural formula, molecular formula and molecular weight:
 |
Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol.
About BioAlliance Pharma
Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.
Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA.
Teva Announces FDA Approval of Generic Adderall XR®
FEB 14 2013, Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for the generic version of Shire’s Adderall XR®Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder. Adderall XR® had annual sales, including brand and generic sales, of approximately $2 billion in the United States, based on IMS sales data as of December 31, 2012.
Teva currently sells a generic version of Adderall XR® Capsules under a 2006 license and distribution agreement with Shire as part of a settlement of patent litigation between Shire and Teva’s subsidiary Barr Pharmaceuticals. Under the terms of the agreement, Teva has the right to be supplied product by Shire through April 1, 2014.
Adderall is a psychostimulant medication that contains amphetamine. It is used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.[1] Adderall is a combination of four amphetamine salts (racemic amphetamine aspartate monohydrate, racemic amphetamine sulfate, dextroamphetamine saccharide, and dextroamphetamine sulfate). It is a dopamine releasing agent, a norepinephrine releasing agent, and can be mildly serotonergic.[2] It is available in two formulations: IR (Instant Release) and XR (Extended Release). The immediate release formulation is indicated for use in attention deficit hyperactivity disorder (ADHD) and narcolepsy,[3] while the XR formulation is approved for use only with attention deficit hyperactivity disorder (ADHD).[2]
Important side effects of therapeutic dextroamphetamine include stunted growth in young people and occasionally a psychosis can occur at therapeutic doses during chronic therapy as a treatment emergent side effect.[4] When abused at high doses, the risk of experiencing side effects and the severity of side effects increases. Side effects may include sweating or shaking.
Like other stimulant drugs, such as methamphetamine and cocaine, Adderall directly affects the mesolimbic reward pathway in the brain. Amphetamine salt preparations are considered to have high abuse potential, and it is classified as Schedule II by the US DEA. With the Safe Streets and Communities Act in Canada, Adderall has been reclassified from Schedule III to Schedule I.[5]
- “Adderall”. The American Society of Health-System Pharmacists. http://www.drugs.com/monograph/adderall.html. Retrieved 3 April 2
- “Adderall XR prescribing information”. Shire US. March 2009. http://pi.shirecontent.com/PI/PDFs/AdderallXR_USA_ENG.PDF. Retrieved 2009-06-23.
- “ADDERALL (CII)” (PDF). Food and Drug Administration. February 2007. http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf. Retrieved 2009-06-23.
- Berman, SM.; Kuczenski, R.; McCracken, JT.; London, ED. (Feb 2009). “Potential adverse effects of amphetamine treatment on brain and behavior: a review.”. Mol Psychiatry 14 (2): 123–42. doi:10.1038/mp.2008.90. PMID 18698321.
- C-10
| Combination of | |
|---|---|
| Dextroamphetamine | Psychostimulant |
| Amphetamine | Psychostimulant |
| Clinical data | |
| Trade names | Adderall, Adderall XR |
| AHFS/Drugs.com | monograph |
| MedlinePlus | a601234 |
| Licence data | US Daily Med:link |
| Pregnancy cat. | C (US) |
| Legal status | Schedule I (CA) Schedule II (US) |
| Dependence liability | High |
| Routes | (Medical) Oral, (Recreational) Oral, Insufflated, Intravenous |
| Identifiers | |
| CAS number | 51-64-9 300-62-9 |
New Drug Approvals 