FDA Actions
July 1, 2014
The FDA has approved the first generic version of the popular non-steroidal anti-inflammatory (NSAID) drug celecoxib (Celebrex). The drug is approved for treatment of osteoarthritis, rheumatoid arthritis, short-term pain, and other conditions. Although the drug has been marketed as a COX-2 inhibitor, it was not removed from the market in the mid-2000s like other COX-2 inhibitors, such as rofecoxib (Vioxx) and valdecoxib (Bextra), which were found to increase the risk for fatal heart attacks and strokes. Celecoxib does, however, carry a boxed warning regarding heart attack risk (as do all NSAIDs), although it appears that non-selective NSAIDs, especially naproxen, may have less cardiovascular risk. Generic celecoxib will initially be marketed by Teva Pharmaceutical Industries (50 mg, 100 mg, 200 mg, and 400 mg strengths) and Mylan Pharmaceuticals (50 mg capsules) during the 180-day exclusivity period, after which other generic manufacturers may enter this potentially lucrative market.
The FDA has approved a new longer-acting factor VIII product for the treatment of children and adults with hemophilia A. The new product is a recombinant factor VIII fused to a protein fragment that requires infusion every 3-5 days rather than every other day or three times a week. The new factor VIII product will be marketed as Eloctate by Biogen Idec.
The FDA has approved a new once-a-week infusion antibiotic for the treatment of skin infections. Dalbavancin is a lipoglycopeptide that treats susceptible gram-positive bacteria, including Streptococcus pyogenes and staph species including methicillin-resistant Staphylococcus aureus (MRSA). The drug is given intravenously in two 30-minute infusions: 1000 mg initially followed by 500 mg 1 week later. The drug was given a priority review and is the first antibiotic designated as a qualified infectious disease product, a new category which the FDA gives to antibiotics that treat serious or life-threatening infections. The drug was approved on the basis of two clinical trials of nearly 1300 patients with acute bacterial skin and skin structure infections which showed that the drug was as effective as vancomycin. Dalbavancin is marketed by Durata Therapeutics as Dalvance.
The FDA has also approved tedizolid for the treatment of acute bacterial skin and skin structure infections caused by susceptible strains of Staphylococcus aureus(including MRSA), various Streptococcus species, and Enterococcus faecalis. The drug is available in both oral and IV preparations. Tedizolid is an oxazolidinone similar to linezolid. Approval of tedizolid was based on the results of two randomized, double-blind Phase 3 trials that demonstrated non-inferiority to linezolid. The drug was also designated as a qualified infectious disease product and received an expedited review. Tedizolid is marketed by Cubist Pharmaceuticals as Sivextro.
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