Lupin bags USFDA nod for hypertension drug Propranolol Hydrochloride ER

Mumbai: Global pharma major Lupin Limited has 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). 

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.