Biopharmaceutical company Halozyme Therapeutics, Inc. announced that the US Food and Drug Administration is still reviewing their new drug application (NDA) for Hylenex recombinant (hyaluronidase human injection).
The agency told the company that it would be unable to meet its Prescription Drug User Fee Act (PDUFA) action date for Hylenex and currently cannot anticipate the timing of FDA's first action, states a company release.
Halozyme is a biopharmaceutical company that focuses on the development and commercialization of recombinant human enzymes and is dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities