Lupin got FDA nod for generic Rheumatoid Arthritis drug

  • Posted on: 11 November 2014
  • By: PharmaTutor News

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(11th November, 2014); Pharma Major Lupin Limited (Lupin) announced that it has received final approval for its Celecoxib Capsules, 50 mg from the United States Food and Drugs Administration (FDA) to market a generic version of G.D. 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 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 US$ 2.44 billion (IMS MAT June, 2014).

Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).


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