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Submitted by PatientsEngage on 5 November 2014

In June 2014, the U.S. Food and Drug Administration (FDA) approved two generic versions of celecoxib (Celebrex).

Developed by Pfizer, celexocib is used to treat rheumatoid arthritis, osteoarthritis, as well as other conditions.

Approval was granted to Mylan Pharmaceuticals, Inc. to market 50 mg celecoxib capsules, while Teva Pharmaceutical Industries received approval to market the drug in the following doses: 50 mg, 100 mg, 200 mg, and 400 mg, according to a bulletin from the FDA. Teva was also awarded exclusivity for 180 days for the 100 mg, 200 mg, and 400 mg capsules.

In November 2014, the U.S. Food and Drug Administration (FDA) has approved Lupin’s celexocib (Celebrex) for its 50 mg capsules to treat arthritis.

In March, Pfizer announced that a U.S. court refused its method of use patent, allowing generic rivals to enter the market early. Reuters reported that analysts estimated the early entrance could cost the company upwards of $3 billion by the end of 2015.

http://www.pharmacylearningnetwork.com/articles/fda-approves-generic-celebrex

http://www.pharmacylearningnetwork.com/articles/fda-approves-generic-version-celebrex

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