Advisory Committee May Review Theravance's NDA

The FDA’s Anti-Infective Drugs Advisory Committee may meet shortly to review Theravance's new drug application (NDA) for telavancin, a once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections.

The agency issued an approvable letter for the drug in October, citing current good manufacturing practices compliance concerns and the need for the submission of revised labeling or the reexamination of clinical data.

Theravance said it will comment further once it receives more information from the FDA.