Lupin gets USFDA nod for arthritis drug
New Delhi: Drug firm Lupin today said it has received approval from the U.S. health regulator to market generic version of GD Searle LLC's Celebrex capsules, used to treat arthritis, in the American market.
The Mumbai-based company has received final approval for its Celecoxib Capsules in 50 mg strength from the United States Food and Drugs Administration (FDA) to market a generic version of GD Searle LLC's Celebrex capsules, Lupin Ltd said in a statement.
The company has also received tentative approvals for its product in strengths of 100 mg, 200 mg and 400 mg from the FDA, it added.
GD Searle LLC's is a subsidiary of Pfizer Inc.
Celecoxib capsules are indicated for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis and acute pain.
According to IMS sales data, Celebrex capsules had annual U.S. sales of $2.44 billion.
Lupin shares today closed at Rs. 1,359 apiece on the BSE, down 0.74 per cent from their previous close.