Lupin Gets USFDA Approval for Generic Hypertension Drug
Lupin receives USFDA approval to market generic hypertension drug Propranolol Hydrochloride extended-release capsules in the US, a generic version of ANI Pharmaceuticals' Inderal LA.
New Delhi, Jan 14 (PTI) Drug maker Lupin on Sunday said it has received approval from the US health regulator to market a generic hypertension drug in America.
The company has received approval from the US Food and Drug Administration (USFDA) for Propranolol Hydrochloride extended-release capsules in multiple strengths, Lupin Ltd said in a regulatory filing.
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.
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.
As per IQVIA MAT November 2023 data, Propranolol Hydrochloride extended-release capsules had estimated annual sales of USD 71 million in the US.
The company has received approval from the US Food and Drug Administration (USFDA) for Propranolol Hydrochloride extended-release capsules in multiple strengths, Lupin Ltd said in a regulatory filing.
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.
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.
As per IQVIA MAT November 2023 data, Propranolol Hydrochloride extended-release capsules had estimated annual sales of USD 71 million in the US.
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