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Lupin gets US FDA approval for Celecoxib Capsules

03 Nov 2014 Evaluate

Pharma Major Lupin has received final approval for its Celecoxib Capsules, 50 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of G.D. Searle LLC’s (a subsidiary of Pfizer Inc.) Celebrex Capsules 50 mg. The company 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 G.D. 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 2 years and older; Ankylosing Spondylitis, and Acute Pain. Celebrex Capsules had annual U.S. sales of $2.44 billion according to IMS MAT June, 2014.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally.

 

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