FDA gives clearance to Caracos generic hypertension drug

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

Dec. 6 – The FDA has granted final approval for Caraco Pharmaceutical Laboratories’ abbreviated new drug application (ANDA) for Amlodipine Besylate tablets, 2.5 mg, 5 mg, and 10 mg (Amlodipine).

The Detroit-based Caraco said its Amlodipine is indicated for the treatment of hypertension, for the symptomatic treatment of chronic stable angina, and for the treatment of confirmed or suspected vasospastic angina. Amlodipine will be a competitor of the brand name Norvasc from Pfizer.