Alembic Pharma gets two approvals from USFDA

Alembic Pharmaceuticals said it received approvals from the United States Food and Drug Administration (USFDA) for sales of a therapeutic equivalent of French pharma major Sanofi Aventis’ Aubagio tablets and for a therapeutic equivalent of Novartis Pharmaceuticals Corporation’s Tobrex Ophthalmic Solution.

Teriflunomide pills are used to reduce flare-ups in people with relapsing multiple sclerosis (MS). It affects the immune system and reduces swelling and inflammation in the nervous system.

Teriflunomide tablets in doses of 7 mg and 14 mg had sales of USD 1.6 billion in the US market for twelve months ending December 2018.

Sanofi Aventis had filed a complaint against Alembic in December 2016 for ‘an act of patent infringement’. Later, the firm closed the litigation on January 5, 2017.

“Alembic has settled the litigation and will launch the product as per the terms of the settlement”, the company said.

Tobramycin Ophthalmic Solution, which belongs to a class of  drugs called aminoglycoside antibiotics is used for the treatment of bacterial eye infections.

As of December 2018, the eye drops in the dose of 0.3% had sales of USD 9.6 million in the US market.

With the latest nods, Alembic has so far received 92 approvals, including 80 final and 12 tentative from the USFDA.

Headquartered in Vadodara, Alembic, manufactures and markets generic pharmaceutical products all over the world.

Established in 1907, it is also one of the leaders in branded generics in India, and has a marketing team of over 5,000 in its home market.