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Generics makers with first-to-file ANDA status say they are frustrated by the FDA’s slow approval times, claiming their 180-day market exclusivity period is jeopardized by agency inaction. Read More
AstraZeneca and Nektar Therapeutics say they hope to market their newly approved opioid-induced constipation drug Movantik in early 2015, but the launch date remains uncertain as the Drug Enforcement Administration considers a request to deschedule the product. Read More
Manufacturers operating in Europe should report any product-quality defect to the drug application holders and individual EU regulatory bodies if the incident requires a recall or creates supply restrictions, according to a revised chapter of a European Commission guideline on good manufacturing practices. Read More
The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers, that laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More
New York’s attorney general has filed what may be a first-of-its-kind antitrust lawsuit against Actavis and subsidiary Forest Laboratories for seeking to switch patients on its Alzheimer’s drug Namenda to a newer formulation with longer lasting patents in order to stave off generic competition. Read More
Indian pharmaceutical authorities have collected only $62 million, or roughly 9 percent, of the $688 million they say drugmakers owe in fines for the overcharging of drugs. Read More