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A federal judge has rejected Pfizer’s request to throw out Mylan Laboratories’ lawsuit challenging the patents on blockbuster blood pressure treatment Norvasc.
The FDA’s Office of Generic Drugs (OGD) has launched its Dissolution Methods Database aimed at improving the quality and turnaround time of abbreviated new drug applications (ANDAs).
Andrx plans to meet with the FDA around Thanksgiving to discuss manufacturing violations that have stalled approval of its drug applications. The company, which requested the meeting, said the FDA has not yet commented on any of its responses to the inspectional observations.
Iceland-based drugmaker Actavis has taken another major step to expand its presence in the generics market, announcing that it plans to purchase Alpharma's U.S. and international generics businesses for roughly $810 million.
An FDA decision that wiped out Teva Pharmaceutical’s market exclusivity for a generic version of Bristol-Myers Squibb’s (BMS) lucrative cholesterol-lowering drug Pravachol (pravastatin sodium) was arbitrary and in violation of federal law, according to a district court judge, who recently granted injunctive relief to Teva.
An FDA decision that wiped out Teva Pharmaceutical’s market exclusivity for a generic version of Bristol-Myers Squibb’s (BMS) lucrative cholesterol-lowering drug Pravachol (pravastatin sodium) was arbitrary and in violation of federal law, according to a district court judge, who recently granted injunctive relief to Teva.
Teva Pharmaceutical has filed an abbreviated new drug application (ANDA) to market a generic version of AstraZeneca’s schizophrenia treatment Seroquel, one of two drugs key to AstraZeneca’s future growth after several recent setbacks.
The FDA’s chief counsel wants to reform the citizen petition process to discourage brand drugmakers from filing petitions simply to delay generic drug debuts.
Wall Street’s outlook for generic companies includes more generic market penetration and a wave of patent expirations, but an influx of authorized generics will hurt the profitability now enjoyed by firms with marketing exclusivity, says one Wall Street observer.