Teva nets tentative FDA approval for generic hypertension drug
The FDA has granted tentative approval for Teva Pharmaceutical Industries’ abbreviated new drug application (ANDA) to market its generic version of Novartis' hypertension treatment Diovan (Valsartan) tablets, 40 mg, 80 mg, 160 mg and 320 mg.
The Jerusalem-based company said it expects final approval of the product upon expiry of patent protection for the brand product in September 2012, as well as any periods of marketing exclusivity that may be awarded.
The brand product had U.S. sales of approximately $1.5 billion for the twelve months ending March 30, according to IMS data.
The Jerusalem-based company said it expects final approval of the product upon expiry of patent protection for the brand product in September 2012, as well as any periods of marketing exclusivity that may be awarded.
The brand product had U.S. sales of approximately $1.5 billion for the twelve months ending March 30, according to IMS data.