Alembic Pharma gets tentative USFDA nod for drug treating hyperuricemia patients

New Delhi: Alembic Pharmaceuticals has received tentative approval from the US health regulator for Febuxostat tablets used for treatment of hyperuricemia in patients of gout.

Pharma1

"The company has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Febuxostat tablets, 40 mg and 80 mg," Alembic Pharmaceuticals said in a BSE filing.

The product is therapeutic equivalent to the reference listed drug Uloric tablets, 40 mg, 80 mg of Takeda Pharmaceuticals USA Inc, it added.

Alembic Pharmaceuticals said it has settled the case with Takeda and will launch its generic as per the terms of settlement.

The tablets, indicated for chronic management of hyperuricemia in patients of gout, has an estimated market size of $430 million for 12 months to December 2015.

The company has 48 ANDA approvals (43 final and 5 tentative from the USFDA.

Alembic stock was trading 0.57 per cent up at Rs 582.75 in the morning trade on BSE.


Updated Date: Jul 05, 2016 12:41 PM

Also Watch

Rethinking pornography: Cyber Sexy author Richa Kaul Padte makes the case for decriminalising porn in India
  • Friday, July 27, 2018 First Day First Showsha — Reviewing Tom Cruise's Mission: Impossible - Fallout in 10 questions
  • Friday, July 27, 2018 It's a Wrap: Karwaan stars Dulquer Salmaan, Mithila Palkar in conversation with Parul Sharma
  • Friday, July 27, 2018 3 alternatives to WhatsApp | What The App
  • Friday, July 27, 2018 Manika Batra interview: Table Tennis star looks back at Commonwealth Games 2018 success, reveals her diet plan and more

Also See