Lupin gets US FDA approval for Bromfenac ophthalmic solution

Lupin Limited, a global pharmaceutical company, on August 16 announced that it has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for a generic version of Bromday Ophthalmic Solution 0.09%, which is produced by Bausch & Lomb Inc.

This generic version, known as Bromfenac Ophthalmic Solution 0.09%, will be manufactured at Lupin's facility in Pithampur. The original Bromday product had approximately $11 million in annual sales in the US as of June 2023.

Earlier this week, the company announced that its unit-2 manufacturing facility located at Mandideep in India has successfully completed a GMP inspection by the United States Food and Drug Administration (USFDA).

Furthermore, earlier in August, Lupin's New Jersey-based subsidiary Novel Laboratories Inc received approvals from the US FDA for two variations of the fluocinolone acetonide oil. The estimated annual sales of the approved combination are around $10 million in the US.