Pharma major Lupin Ltd has received the United States Food and Drug Administration (US FDA) approval for its Abbreviated New Drug Application (ANDA) for Propranolol Hydrochloride Extended-Release Capsules USP, 60 mg, 80 mg, 120 mg, and 160 mg.
The capsules had estimated annual sales of $71 million in the US, Lupin said in a stock exchange filing.
It is indicated for the management of hypertension, to decrease angina frequency and increase exercise tolerance in patients with angina pectoris, for treatment of common migraine headaches, and hypertrophic subaortic stenosis.
According to the company’s filing, the product is a generic equivalent of Inderal LA Extended-Release Capsules, 60 mg, 80 mg, 120 mg, and 160 mg, of ANI Pharmaceuticals, Inc.
In addition, Lupin recently announced the launch of Varenicline Tablets, 0.5 mg and 1 mg.