Cefotan Inj Regains Approval After Discontinuation
Teligent announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Cefotan (cefotetan) for Injection. This new approval addresses the shortage in treatment since Cefotan was discontinued by AstraZeneca last year.
Cefotan is a cephalosporin antibiotic indicated for the treatment of susceptible lower respiratory tract or urinary tract, skin and skin structure, bone and joint, gynecologic, intraabdominal infections; and for use in surgical prophylaxis. The bactericidal action of cefotetan results from inhibition of cell wall synthesis.
Cefotan for Injection will be available as 1g and 2g strength vials. It is anticipated to launch in early 2016.
For more information call (856) 697-4397 or visit teligent.com.