By: IPP Bureau
Last updated : January 15, 2024 10:47 am
Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) 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.
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, Angina Pectoris due to Coronary Atherosclerosis, Migraine, and Hypertrophic Subaortic Stenosis.
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 headaches. 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 US $71 million in the US (IQVIA MAT November 2023).