- Alembic Pharmaceutical and Zydus Cadila get approvals from U.S. FDA
- Alembic Pharmaceutical can't sell the drug right now, due to an ongoing litigation with Bayer Healthcare in a Delware Court.
- Zydus Cadila can now sell a generic drug used to treat blood pressure in the U.S.
The U.S. pharma watchdog has approved two generic drugs made by Indian companies. The approvals come within weeks of the U.S. Food and Drug Administration deciding to fast-track the process to bring down medicine prices.
Alembic Pharmaceuticals Ltd. has got tentative nod to sell a generic version of an oral drug used to treat erectile dysfunction. The medicine is a generic version of a formula first developed by Bayer Healthcare, said Alembic Pharmaceutical in an exchange filing.
Alembic Pharmaceuticals can't sell the drug immediately though due to an ongoing litigation with Bayer Healthcare in a Delware court, added the company.
The drug had a market size of around $9.5 million in the last financial year, said the company, quoting research firm IMS Health.
The company's Abbreviated New Drug Application (ANDA) tally now stands at 59, 52 of which are final approvals.
Zydus Cadila has also got a go-ahead from the U.S. FDA to launch Sitagilptin and Metformin Hydrochloride tablets used to treat blood sugar levels. The company now has more than 120 approvals from the pharma watchdog and has filed over 300 ANDAs since the filing process began, the company said in an exchange filing.
Also Read: Faster Approvals By U.S. FDA To Hurt Indian Drugmakers, Says Credit Suisse
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