New FDA Aprrivals
These drugs have received final approval from the U.S. Food and Drug Administration:
- Hyperparathyroidism agent Zemplar (paricalcitol injection) by Abbott Laboratories. A synthetically manufactured vitamin D analog indicated for prevention/treatment of secondary hyperparathyroidism associated with chronic renal failure. 5 mcg/ mL supplied in 1 and 2 mL single-dose fliptop vials.
- Antiepileptic drug Trileptal (oxcarbazepine) by Novartis Pharmaceuticals. Trileptal indicated for monotherapy or adjunctive therapy in treatment of partial seizures in adults with epilepsy and as adjunctive therapy in treatment of partial seizures in children ages 4-16 with epilepsy. Available in 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration.
- Proton pump inhibitor Protonix (pantoprazole sodium) Delayed-Release tablets by Wyeth-Ayerst Laboratories. Approved for short-term treatment (up to eight weeks) in healing and symptomatic relief of erosive esophagitis asso ciated with gastroesophageal reflux disease. Available in 40 mg delayed-release tablet for oral admin istration.
- Irritable bowel syndrome agent Lotronex (alosetron HCl) by Glaxo Wellcome. A 5-HT3 receptor antagonist indicated for treatment of irritable bowel syndrome in women whose predominant bowel symptom is diarrhea. Safety and effectiveness in men have not been established. Available in 1 mg film-coated tablets for oral use.
- Antidepressant agent Bupropion tablets, by Invamed Inc. Approved as generic equivalent to Glaxo’s Wellbutrin. Approval includes the marketing of 75 mg and 100 mg tablets.
- New indication for treatment of familial adenomatous polyposis (FAP) for Celebrex (celecoxib) by Searle. New indication for COX-2 inhibitor provides treatment for reducing number of colorectal polyps in patients with FAP and should be used only as an adjunct to normal care. Granted accelerated approval for the new indication.
- New indication for Levaquin (levofloxacin) by RW Johnson. Indication is for treatment of levofloxacin-susceptible strains of penicillin-resistant Streptococcus pneumoniae in patients with community-acquired pneumonia. New indication applies to both tablet and injectable formulations.