Lupin Limited announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Propranolol Hydrochloride Extended-Release Capsules USP, 60 mg, 80 mg, 120 mg, and 160 mg, to market a generic equivalent of Inderal® LA Extended- Release Capsules, 60 mg, 80 mg, 120 mg, and 160 mg, of ANI Pharmaceuticals Inc. The product will be manufactured at Lupin's Pithampur facility in India. Propranolol Hydrochloride Extended-Release Capsules USP, 60 mg, 80 mg, 120 mg, and 160 mg are indicated for: Hypertension: Propranolol Hydrochloride Extended-Release Capsules USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic.

Propranolol Hydrochloride Extended-Release Capsules USP are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis: Propranolol Hydrochloride Extended-Release Capsules USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine: Propranolol Hydrochloride Extended-Release Capsules USP are indicated for the prophylaxis of common migraine headache.

The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Hypertrophic Subaortic Stenosis: Propranolol Hydrochloride Extended-Release Capsules USP improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol Hydrochloride Extended-Release Capsules USP (RLD Inderal® LA) had estimated annual sales of USD 71 million in the U.S. (IQVIA MAT November 2023).