Tuesday, 29 September 2020


FDA nod for Lupin's angina generic Ranolazine

05 August 2013 | News | By BioSpectrum Bureau

Ranolazine extended-release tablets are indicated for treatment of chronic angina.

Ranolazine extended-release tablets are indicated for treatment of chronic angina.

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.


Sign up for the editor pick and get articles like this delivered right to your inbox.

Editors Pick
+Country Code-Phone Number(xxx-xxxxxxx)


Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account