First Generic Versions Of Pfizer's Celebrex Approved By The FDA

The U.S. Food and Drug Administration (FDA) announced that it has granted approval to Teva and Mylan’s generic versions of Pfizer’s Celebrex (celecoxib).

Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID) developed by Pfizer as a treatment for rheumatoid arthritis, acute pain, osteoarthritis, and other conditions.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said, “It is important for patients to have access to affordable treatment options for chronic conditions. Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Teva received FDA approval to commercialize generic versions of celecoxib in 50 mg, 100 mg, 200 mg, and 400 mg strengths. In addition, the company received a 180 day marketing exclusivity on the 100 mg, 200 mg, and 400 mg products. Teva previously arranged with Pfizer to launch the generic version of Celebrex in December 2014, or earlier depending on certain circumstances. The company said it has been granted tentative approval from the FDA to market celecoxib tablets in all strengths.

Mylan, on the other hand, received approval to market 50 mg celecoxib capsules. The company previously challenged the FDA’s decision on generic drug marketing exclusivity on celecoxib capsules. “Mylan continues to believe that FDA seriously erred in its decision regarding eligibility for 180 days of exclusivity on Celecoxib. Mylan will review all of its options, including filing an expedited appeal in the United States Court of Appeals for the Fourth Circuit,” the company stated in its press release. Mylan has also received tentative approval from the FDA on all celecoxib strengths.

Generic prescription drugs must demonstrate similar high-quality and strength as branded drugs. Drug manufacturing and packaging sites must be able to pass FDA quality standards as those of the original brand-name products.