FDA gives Lupin tentative OK for 2 generics

The Food and Drug Administration has given Lupin a tentative nod for two new generics.

The first medication is loteprednol etabonate ophthalmic gel, 0.38%, which is a generic of Bausch & Lomb’s Lotemax.

Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. This product would be manufactured at Lupin’s Pithampur facility in India.

Loteprednol etabonate ophthalmic gel, 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

[Read more: FDA gives Lupin tentative nod for generic Janumet]

Loteprednol etabonate ophthalmic gel, 0.38% had a market value of roughly $36 million, per IQVIA November 2024 data.

Lupin also received tentative approval from the FDA for ivacaftor oral granules, 25 mg, 50 mg and 75 mg per unit dose packet, which is a generic of Vertex’s Kalydeco.

Lupin is the exclusive first-to-file for this product and may be eligible for 180 days of generic drug exclusivity. This product would be manufactured at Lupin’s Nagpur facility in India.

[Read more: FDA gives Lupin tentative OK for generic Triumeq PD]

Ivacaftor oral granules are indicated for the treatment of cystic fibrosis in patients aged 4 months and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor.

Ivacaftor oral granules, 25 mg, 50 mg and 75 mg had a market value of roughly $51 million, per IQVIA November 2024 data.