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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Let’s Set a Global Drug Quality Benchmark by Kiran M Shaw, Biocon
See on Scoop.it – New drug approvals
With Indian-made generics accounting for a US market share of over 25 per cent, it is not surprising that it is gaining significant mindshare of the Food and Drug Administration ( FDA). The spate o…
Let’s Set a Global Drug Quality Benchmark by Kiran M Shaw, Biocon
With Indian-made generics accounting for a US market share of over 25 per cent, it is not surprising that it is gaining significant mindshare of the Food and Drug Administration ( FDA). The spate of quality issues with leading Indian pharmaceutical companies in the past couple of years however should not be viewed in isolation. Big Pharma in the West, too, has been facing increasing flak from the FDA and other regulators over good manufacturing practice ( GMP) violations. High profile names like J& J, Genzyme (Sanofi), GSK, Sandoz, Watson, Teva and many others have encountered their share of quality problems and have been served with ‘warning letters’ from FDA
http://kiranmazumdarshaw.blogspot.in/2013/06/lets-set-global-drug-quality-benchmark.html
READ ALL AT THE LINK ABOVE
Adamas claims success with new and improved Parkinson’s drug
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amantadine Adamas claims success with new and improved Parkinson’s drug Adamas Pharmaceuticals is claiming success with a Phase II/III study of its extended-release version of amantadine for Parkin…
Medicinal Plants Used To Treat Sexual Dysfunction- A review
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Medicinal Plants Used To Treat Sexual Dysfunction: A Review by Ramandeep et al. Int J Recent Adv Pharm Res, 2013;3(1):29-35. ISSN: 2230-9306; www.ijrapronline.com. 29. Medicinal Plants Used To Tr…
Medicinal Plants Used To Treat Sexual Dysfunction- A review
See on Scoop.it – New drug approvals
Medicinal Plants Used To Treat Sexual Dysfunction: A Review by Ramandeep et al. Int J Recent Adv Pharm Res, 2013;3(1):29-35. ISSN: 2230-9306; www.ijrapronline.com. 29. Medicinal Plants Used To Tr…
Adamas claims success with new and improved Parkinson’s drug
See on Scoop.it – New drug approvals
amantadine Adamas claims success with new and improved Parkinson’s drug Adamas Pharmaceuticals is claiming success with a Phase II/III study of its extended-release version of amantadine for Parkin…
Adamas claims success with new and improved Parkinson’s drug
amantadine
Adamas claims success with new and improved Parkinson’s drug
Amantadine (trade name Symmetrel, by Endo Pharmaceuticals) is a drug that has US Food and Drug Administration approval for use both as an antiviral and an antiparkinsonian drug. It is the organic compound 1-adamantylamine or 1-aminoadamantane, meaning it consists of an adamantane backbone that has an amino group substituted at one of the four methyne positions. Rimantadine is a closely related derivative of adamantane with similar biological properties.
Apart from medical uses, this compound is useful as a building block, allowing the insertion of an adamantyl group.
According to the US Centers for Disease Control and Prevention, 100% of seasonal H3N2 and 2009 pandemic flu samples tested have shown resistance to adamantanes, and amantadine is no longer recommended for treatment of influenza in the United States. Additionally, its effectiveness as an antiparkinsonian drug is undetermined, with a 2003 Cochrane Review concluding that there was insufficient evidence in support or against its efficacy and safety.
Synthesis
Amantadine may be prepared by reacting adamantane with bromine or nitric acid to give the bromide or nitroester at position one. Reaction of either compound with acetonitrile affords the acetamide, which is hydrolyzed to give 1-adamantylamine:
New Drug Approval Process: Regulatory View
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New Drug Approval Process: Regulatory View
http://www.pharmainfo.net/reviews/new-drug-approval-process-regulatory-view
Celgene saw the firm get European approval for Revlimid as a treatment for a rare form of blood disease
lenalidomide
European Commission has expanded approval on Revlimid (lenalidomide) to allow treatment of patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes (MDS) with an isolated chromosomal abnormality called deletion 5q when other options do not work. MDS is a type of cancer where the production of blood cells and platelets by the bone marrow is disrupted, which can often lead to severe anemia, infections and bleeding.
DR ANTHONY MELVIN CRASTO
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New Drug Approvals 