U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act).
Allecra Therapeutics Announces U.S. FDA Approval for EXBLIFEP
Allecra Licensor Advanz receives positive CHMP opinion for EXBLIFEP
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended granting a marketing authorization for EXBLIFEP. Advanz will commercialise EXBLIFEP® across Europe once approved and continues its journey to strengthen its portfolio of innovative medicines in areas with high patient need.
Allecra Therapeutics Submits New Drug Application to the U.S. FDA
Allecra Therapeutics Submits New Drug Application to the U.S. FDA for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs)