FDA Approves Caraco's Generic Norvasc

Caraco Pharmaceutical Laboratories received approval from the FDA for the company’s abbreviated new drug application for amlodipine besylate tablets, 2.5 mg, 5 mg and 10 mg.

 

Amlodipine is the bioequivalent to Pfizer’s Norvasc and is indicated for the treatment of hypertension, chronic stable angina confirmed or suspected vasospastic angina.

Based on the most recent quarterly sales, amlodipine generic and brand products have a run rate of approximately $550 million, Caraco said.