Lupin gets US FDA approval for generic Celebrex capsules

Lupin has received final approval for its Celecoxib capsules, 50 mg from the US Food and Drugs Administration (FDA) to market a generic version of GD Searle LLC’s (a subsidiary of Pfizer Inc.) Celebrex capsules 50 mg. Lupin also received tentative approvals for its Celecoxib capsules 100 mg, 200 mg and 400 mg strengths from the FDA.

Lupin’s Celecoxib capsules 50 mg, 100 mg, 200 mg and 400 mg are the AB-rated generic equivalents of GD Searle LLC ‘s Celebrex capsules 50 mg, 100 mg, 200 mg and 400mg and are indicated for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients two years and older; ankylosing spondylitis, and acute pain.

Celebrex capsules had annual US sales of US$ 2.44 billion (IMS MAT June, 2014).

EP News BureauMumbai

Comments (0)
Add Comment