05 Aug 2013, BioSpectrum Bureau , BioSpectrum
Mumbai: Lupin Phamaceuticals has received final approval for its Ranolazine extended-release tablets, 500 mg and 1000 mg from the US FDA.
Lupin's Ranolazine extended-release tablets are the AB-rated generic equivalent of Gilead Sciences' Ranexa extended-release tablets, 500 mg and 1000 mg strengths. Ranolazine extended-release tablets are indicated for treatment of chronic angina.
Lupin believes that it is the first applicant to file an ANDA (abbreviated new drug application) for Ranexa extended-release tablets 500 mg and 1000 mg strengths and as such will be entitled to 180 days of marketing exclusivity.