Unichem Labs osteoarthritis drug Celecoxib gets USFDA okay
The capsules are generic versions of GD Searle LLC's Celebrex capsules in the same strengths, it added.
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 the 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 StatesFood 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 the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea," it added.
