FDA gives Lupin nod for generic Pred Forte, tentative OK for generic Descovy

Lupin has received the Food and Drug Administration’s approval for Prednisolone Acetate Ophthalmic Suspension, 1% which is a generic of AbbVie’s Pred Forte Ophthalmic Suspension.

Lupin was granted a Competitive Generic Therapy designation for this product, and being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity.

The product will be manufactured at Lupin’s Pithampur facility in India.

Prednisolone Acetate Ophthalmic Suspension, 1% is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

[Read more: Lupin receives FDA OK for generic Banzel]

Prednisolone Acetate Ophthalmic Suspension had a market value of roughly $98 million, per IQVIA June 2024 data.

Lupin also has received tentative approval from the Food and Drug Administration under the U.S. President’s Emergency Plan for AIDS Relief for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg, which is a generic of Gilead Sciences’ Descovy.

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries. 

Emtricitabine and Tenofovir Alafenamide Tablets are indicated to treat or prevent HIV-1 infection in adults and children who weigh at least 35 kg.

[Read more: Lupin receives FDA nod for 3 generics]

Naresh Gupta, president of API and global institution business, Lupin said, “Lupin is committed to offering affordable, quality treatments for patients. The tentative approval from the U.S. FDA for our Emtricitabine and Tenofovir Alafenamide Tablets significantly enhances our HIV medicine offering.”