Search Results for "Fda Anda Approvals"
Original Source: Watson wins FDA approval for progestin-only emergency contraceptive
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has gained FDA abbreviated new drug application (ANDA) approval for Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg).
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In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in e...
Clinical Approvals - news, views, reports and blogs
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and eff...
BioPortfolio has created a number of Twitter accounts to help you keep upto date on the latest news, research papers, reports and clinical trials on a selected range of important and popular topics....
BioPortfolio has launched a number of Facebook pages to allow our visitors to keep track with latest news, published paper and clinical trials by lead biotechnology and healthcare topics:- &nbs...
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Type: Brief CommunicationThe Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the...
Thomson Reuters Quarterly Report on U.S. Generic Drug Industry
24th May 2013: Thomson Reuters Movers and Shakers quarterly report, focusing on the U.S. generic drug industry. Movers and Shakers is the best source of information on generic approvals and...
FDA approves Mylan ANDA for Pioglitazone tablets
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) for Pioglitazone tablets USP, 15mg, 30mg and 45mg.
FDA approves Sun Pharma ANDA for generic Doxil
The US Food and Drug Administration (FDA) has approved Sun Pharmaceutical Industries' abbreviated new drug application (ANDA) for Doxorubicin HCl Liposome Injection USP, 2 mg/ml.
Watson submits ANDA for generic cancer drug
Watson Pharmaceuticals confirmed on 28 December 2012 that Actavis, which was acquired by Watson in October 2012, has filed an Abbreviated New Drug Application (ANDA) with FDA seeking approval to marke...
FDA approves Cornerstone ANDA for gneric Tussionex Pennkinetic product
Cornerstone Therapeutics, a specialty pharmaceutical company, has received FDA approval for its abbreviated new drug application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polist...
FDA approves Cornerstone's ANDA for gneric Tussionex Pennkinetic product
Cornerstone Therapeutics, a specialty pharmaceutical company, has received FDA approval for its abbreviated new drug application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polist...
FDA approves Mylan's ANDA for Acyclovir Ointment
The US FDA has granted final approval for Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Acyclovir Ointment USP, 5%.
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Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA.
The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the World Health Organizatio...
Why are multi-centre clinical observational studies still so difficult to run?
Despite the introduction of IRAS, obtaining R&D approvals for multicentre studies is a major rate limiting step. Our experience with cleft research demonstrates that this approvals process must be dra...
Drug updates and approvals: 2012 in review.
This paper investigates the impact of the introduction of new orphan drugs on premature mortality from rare diseases using longitudinal, disease-level data obtained from a number of major databases. T...
