
USFDA14 Jan 2024, 01:52 pm
Lupin Receives FDA Approval for Propranolol Hydrochloride ER Capsules
AI Summary
Lupin Limited has received approval from the US FDA for its Abbreviated New Drug Application for Propranolol Hydrochloride Extended-Release Capsules USP, to market a generic equivalent of Inderal® LA Extended-Release Capsules, 60 mg, 80 mg, 120 mg, and 160 mg, for the management of hypertension, angina pectoris, and migraine headache.,
Key Highlights
- Received FDA approval for Propranolol Hydrochloride ER Capsules
- First generic equivalent of Inderal® LA Extended-Release Capsules
- Indicated for hypertension, angina pectoris, and migraine headache
- Manufactured at Lupin's Pithampur facility in India