FDA actions in brief

FDA approval information regarding zoledronic acid (Reclast injection), somatropin (rDNA origin) injection (Norditropin), clopidogrel 300-mg loading dose (Plavix), IV and oral levofloxacin (Levaquin), thrombin, topical (human) (Evithrom), amlodipine/olmesartan (Azor), and docetaxel injection concentrate (Taxotere)

Key Points

Zoledronic acid (Reclast Injection, Novartis) was approved for the once-yearly treatment of osteoporosis in postmenopausal women.

FDA approved somatropin (rDNA origin) injection (Norditropin, Novo Nordisk) for the treatment of children with short stature associated with Turner syndrome.

A 300-mg loading dose tablet of clopidogrel (Plavix, Sanofi-Aventis/Bristol-Myers Squibb) was approved for the reduction of atherothrombotic events.

Thrombin, topical (human) (Evithrom, Omrix) was approved as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical.

A combination of amlodipine and olmesartan (Azor, Daiichi Sankyo/Forest) was approved for the treatment of hypertension.

Docetaxel injection concentrate (Taxotere, Sanofi-Aventis) was approved in combination with cisplatin and 5-fluorouracil for induction therapy of locally advanced squamous cell carcinoma of the head and neck before patients undergo chemoradiotherapy and surgery.