Lupin gets third USFDA approval for new drug in less than a week; shares in focus tomorrow

livemint.com:

Lupin announced on Sunday, January 14, that it has received approval from the US health regulator to market a generic drug to treat migraine and hypertension. The Mumbai-based company has received the nod from the US Food and Drug Administration (USFDA) for Propranolol Hydrochloride extended-release capsules in multiple strengths, said Lupin Ltd in a regulatory filing to the stock exchanges today. The company's product is the generic version of ANI Pharmaceuticals' Inderal LA extended-release capsules, it added.

The product will be manufactured at the company's Pithampur-based manufacturing plant, the drug firm stated. This is third new launch announced by the company in the last one week. The other two approvals were Varenicline tablets - recommended in the treatment of smoking addictions and dry eye disease, and bromfenac ophthalmic solution - which is used to treat inflammation and pain among patients who have undergone cataract surgery.

Propranolol Hydrochloride extended-release capsules USP are indicated in the management of hypertension. They may be used alone or in combination with other antihypertensive agents, particularly a thiazide diuretic. According to IQVIA MAT November 2023 data, Propranolol Hydrochloride extended-release capsules had estimated annual sales of $71 million in the US.

According to Lupin, Propranolol Hydrochloride Extended-Release Capsules USP, 60 mg, 80 mg, 120 mg, and 160 mg are indicated for: -Hypertension The capasules 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