FDA Import Alert Lifted, Apotex Says; Will Lipitor ANDA Approvals Be Far Behind?
Apotex’s announcement that FDA is lifting an import alert on products manufactured at two Canadian facilities could be interpreted as a good sign for the near-term availability of Lipitor generics, either from first-filer Ranbaxy Laboratories Ltd. or subsequent ANDA filers.
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The agency’s “inexcusable delay” in granting final approval of Apotex’s ANDAs for Avapro and Avalide has caused the company to “fall fatally behind” in the marketplace now that 180-day exclusivity for the antihypertensive agents has expired, the manufacturer alleges.
Apotex claims an FDA import alert on two of its facilities caused damages in excess of $520 million; its complaint alleging U.S. government violation of NAFTA is the second it has brought before the International Centre for Settlement of Investment Disputes.
MUMBAI - Two years after Pfizer Inc. filed a patent infringement lawsuit against India's Dr. Reddy's Laboratories Ltd. in a bid to ward off threats to its blockbuster brand Lipitor (atorvastatin), the two companies filed a joint motion Aug. 19 to dismiss the case at the U.S. District Court of Delaware. The case was dismissed Aug. 29 but the terms and conditions of the settlement and a likely launch date for the generic versions of Dr. Reddy's product were not disclosed