USFDA6 Feb 2024, 10:44 pm
Lupin Receives FDA Approval for Bromfenac Ophthalmic Solution
AI Summary
Lupin Limited has received approval from the US FDA for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, a generic equivalent of BromSite® Ophthalmic Solution of Sun Pharmaceutical Industries Limited. This product will be manufactured at Lupin's Pithampur facility in India and is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.,
Key Highlights
- Lupin receives FDA approval for Bromfenac Ophthalmic Solution
- First-to-file exclusive for this product
- Manufactured at Lupin's Pithampur facility in India
- Indicated for postoperative inflammation and ocular pain in cataract surgery patients