Leading drug maker 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 emergencies.
-Angina Pectoris Due to Coronary Atherosclerosis
The capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
-Migraine
The capsules 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
The capsules improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
On Friday, shares of Lupin settled 0.06 per cent lower at ₹1,398.45 apiece on the BSE. After the latest approvals from the USFDA, shares of the drug maker will be in focus tomorrow, January 15. Shares of Lupin have rallied around 92 per cent in the last one year.
