FDA Actions in Brief June 2010 (Vimovo, CIP-Tramadol ER, Zymaxid, Lumizyme, Rapamune, Sprix)

Recent FDA Approvals (through May 2010) related to Vimovo, CIP-Tramadol ER, Zymaxid, Lumizyme, Rapamune, Sprix

Naproxen and esomeprazole magnesium (Vimovo, AstraZeneca and Pozen) delayed-release tablets were approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

Extended-release tramadol (CIP-Tramadol ER, Cipher) was approved for the treatment of moderate-to-moderately severe chronic pain in adults. Strengthened warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressants, and the risk of overdosage.

Gatifloxacin ophthalmic solution (Zymaxid, Allergan) 0.5% was approved for the treatment of bacterial conjunctivitis caused by susceptible strains of Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, and Streptococcus pneumoniae.

A 0.5-mg lower-dosage strength tablet of sirolimus (Rapamune, Pfizer) was approved for the prophylaxis of organ rejection in patients aged >13 years receiving kidney transplants, with specific regimens recommended for use in patients at low-to-moderate immunologic risk and in patients at high immunologic risk.

Ketorolac tromethamine nasal spray (Sprix, Roxro) was approved for the short-term (up to 5 days) management of acute moderate-to-moderately severe pain that requires analgesia at the opioid level.