Pharma major Lupin receives US FDA approval for generic eye solution

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Global pharmaceutical giant Lupin announced on Monday (May 6) that it has secured approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for travoprost ophthalmic solution USP, 0.004% (ionic buffered solution).

This approval allows Lupin to market a generic equivalent to the reference listed drug (RLD) Travatan Z ophthalmic solution, 0.004%, which is manufactured by Sandoz Inc.

The generic product, travoprost ophthalmic solution USP, 0.004%, will be produced at Lupin’s facility in Pithampur, Madhya Pradesh.

Travoprost ophthalmic solution USP, 0.004%, is specifically indicated for the reduction of elevated intraocular pressure in patients diagnosed with eye conditions like open-angle glaucoma or ocular hypertension. This approval is poised to offer patients in the United States access to a more affordable alternative.

According to IQVIA MAT March 2024, the reference listed drug (RLD) Travatan Z ophthalmic solution, 0.004%, had estimated annual sales of $77 million in the US.

Also Read: Aurobindo Pharma’s Rajasthan unit gets 7 observations from US FDA

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow