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.
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