FDA to consider two injectable antibiotics

WASHINGTON The Food and Drug Administration’s Anti-Infective Drugs Advisory Committee is ready to consider two investigational antibiotics from Theravance and Johnson & Johnson that are currently under agency review for the treatment of complicated skin and skin structure infections.

The meetings will occur at the end of next month, with Theravance’s telavancin, an injectable antibiotic, being considered first on the 27th. If the application is approved, Theravance said it will “collaborate substantially” with development partner Astellas in marketing the drug during its first three years on the market.

Johnson & Johnson will meet the committee the following day to go over its injectable antibiotic ceftobiprole medocaril, a broad-spectrum cephalosporin.