New FDA Approvals
These drugs recently received final approval from the Food and Drug Administration (FDA):
• Cefditoren pivoxil (Spectracef) by TAP Pharmaceutical Products. The FDA has approved a new cephalosporin antibiotic, Spectracef (cefditoren pivoxil). Spectracef is indicated for the treatment of the following: mild-to-moderate infections in adults and adolescents (12 years of age or older), acute exacerbations of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections.
• Zoledronic acid for injection (Zometa 4 mg) by Novartis. The FDA has approved zoledronic acid for injection (Zometa 4 mg) for the treatment of hypercalcemia of malignancy, a common life-threatening metabolic complication associated with cancer. Zometa is an intravenous bisphosphonate that works by inhibiting the breakdown of bone (resorption).
• Zolmitriptan Orally Disintegrating Tablet by AstraZeneca. The FDA announced the approval of a new 5 mg strength zolmitriptan (Zomig-ZMT) Orally Disintegrating Tablet for the treatment of migraine in adults, following the recent approval of Zomig-ZMT 2.5 mg. Zomig-ZMT 5 mg, like the 2.5 mg, is an orange-flavored tablet that dissolves on the tongue in seconds without the need for additional liquids.
• Budesonide (Entocort EC) capsules by AstraZeneca. The FDA has approved budesonide (Entocort EC) capsules for the treatment of mild-to-moderate active Crohn’s disease involving certain sections of the small and large intestines. Entocort EC is an orally administered steroid that is released in the intestine, where it works locally and topically to decrease inflammation. Unlike other steroids used to treat Crohn’s disease, most of Entocort EC is not absorbed into the body.
• Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing) by Organon. The FDA has given approval to market etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), the first monthly vaginal ring for birth control. NuvaRing is a flexible, transparent ring that provides month-long contraceptive protection and can be discretely administered by a woman in her own home. The product works by releasing a continuous low dose of estrogen and progestin, on average 0.120 mg of etonogestrel and 0.015 mg of ethinyl estradiol, per day over a 21-day period of use.