FDA Approves And U.S. District Court Affirms Teva's Generic Celebrex
By Cyndi Root
Last week, the Food and Drug Administration (FDA) announced in a press release that it has approved the first generic versions of Celebrex (celecoxib) capsules.
Teva Pharmaceutical Industries announced the same day, that a U.S. District court affirmed the FDA’s approval, denying a motion filed by Mylan and granting Teva the 180-day “first-to-file” exclusivity rights. Mylan in its response, states that the FDA and the Court have “seriously erred.”
Janet Woodcock of the FDA stated that it is important for patients to have affordable drugs that are the same quality as branded drugs. “It is important for patients to have access to affordable treatment options for chronic conditions,” said Woodcock. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”
Celebrex
Celebrex (celecoxib) is a drug for painful conditions like rheumatoid arthritis and osteoarthritis. The non-steroidal anti-inflammatory drug (NSAID) carries risks of heart attack, stroke, and gastrointestinal (GI) bleeding. Patients should take the drug exactly as prescribed, at the lowest dose possible, and for the shortest time needed.
Teva is FDA approved to market the 50 mg, 100 mg, 200 mg, and 400 mg strengths of celecoxib, with 180-day exclusivity for all except the 50 mg strength. Mylan Pharmaceuticals is approved to market the 50 mg. Teva settled with Pfizer in April 2014 on the 50, 100, 200, and 400 mg generic capsules, giving Teva the rights to launch celecoxib by the end of the year.
U.S. Court Decision
The U.S. District Court for the Northern District of West Virginia denied Mylan’s motion that Teva should not have exclusivity to market celecoxib. Mylan’s proposed injunction against the FDA challenged the agency's decision regarding marketing exclusivity. Mylan states that the FDA erred in its decision and it intends to review its options, one of which includes an expedited appeal in the United States Court of Appeals for the Fourth Circuit.
About Teva Generics
Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceutical Industries in Israel. Teva Generics manufactures and markets generics in the U.S. The company states that the U.S. generics market is worth $3.4 billion yearly, saving Americans $217 billion on name brand drugs. Teva bases its operations near Philadelphia, PA. Generics include tablets, capsules, injectables, and suspensions for a variety of diseases and conditions, including cardiovascular, anti-infective, and analgesic.