Tetraphase Pharmaceuticals Announces FDA Acceptance for Filing of its NDA Submission for Eravacycline

Tetraphase Pharmaceuticals (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the FDA has completed its initial 60-day review of the New Drug Application (NDA) for eravacycline for the treatment of complicated intra-abdominal infections (cIAI), and determined that the application is sufficiently complete to permit a substantive review.

As quoted in the press release:

“The FDA’s acceptance for review of our NDA submission for IV eravacycline in cIAI marks an important step in our goal to bring this important new treatment option to patients in need,” said Guy Macdonald, President and CEO of Tetraphase. “We believe that eravacycline has the potential to play a key role in the treatment of serious intra-abdominal infections, particularly Gram-negative infections, and we look forward to providing an update on a regulatory decision in August as we continue to prepare for a commercial launch.”

Click here to read the full press release.