TAP Receives FDA Approval for New Cephalosporin Antibiotic SPECTRACEF™ (Cedfditoren Pivoxil)

09-17-2001: TAP Pharmaceutical Products Inc. announced today that it has received U.S. Food and Drug Administration (FDA) approval for 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 (AECB), pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections.

"TAP is excited about the approval of SPECTRACEF as it will provide physicians and patients a new treatment option," said Thomas Watkins, president, TAP.

SPECTRACEF 200 mg is indicated for the treatment of pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes (S. pyogenes); and uncomplicated skin and skin structure infections caused by susceptible strains of Staphylococcus aureus or S. pyogenes; and 400 mg for the treatment of AECB caused by susceptible strains of Haemophilus influenzae (H. influenzae), H. parainfluenzae, S. pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis. Similar to other antibiotics it should be taken twice a day for 10 days. The approval of SPECTRACEF by the FDA is supported by data from more than 4,000 patients in clinical trials.

Overall side effects in SPECTRACEF-treated patients were generally mild and self-limiting.

The most commonly reported adverse events for SPECTRACEF in clinical trials were diarrhea, nausea and vaginal moniliasis (yeast infection).

SPECTRACEF is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components, and in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency. SPECTRACEF should not be administered to patients with milk protein (sodium caseinate) hypersensitivity (not lactose intolerance). For further information, please refer to the complete prescribing information.

TAP licensed cefditoren pivoxil, one of the top-prescribed cephalosporins in Japan, from Tokyo-based Meiji Seika Kaisha, Ltd. Physicians in Japan have written an estimated 41 million prescriptions for cefditoren since its launch more than seven years ago.