Unichem Labs gets American drug regulator's nod to market generic Celecoxib capsules

NEW DELHI: Drug firm Unichem Laboratories on Wednesday said it has received approval from the US health regulator to market its generic Celecoxib capsules used for treatment of osteoarthritis, rheumatoid arthritis and acute pain. The company has received abbreviated new drug application (ANDA) approval for its Celecoxib capsules in the strengths of 50 mg, 100 mg, 200 mg, and 400 mg from the United States Food and Drug Administration (USFDA), Unichem said in a filing to BSE.
The capsules are generic versions of GD Searle LLC's Celebrex capsules in the same strengths, it added.

The product will be commercialized from the company's Goa plant, the filing said.

"Celecoxib capsules are indicated for treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea," it added.

Shares of Unichem Laboratories were trading at Rs 280.55 per scrip on BSE, up 1.04 per cent from its previous close.