WASHINGTON, Dec 21 (Reuters) - U.S. regulators have asked Pfizer Inc (PFE.N) to provide additional data before they decide whether to approve an experimental antibiotic to treat skin infections, the company said on Friday.
The drugmaker said the U.S. Food and Drug Administration sent an “approvable” letter for dalbavancin, which the company is developing for adults with complicated skin infections including methicillan-resistant Staphylococcus aureus, or MRSA.
Approvable letters mean the agency will clear a medicine for sale if certain conditions are met.
The FDA recently published draft guidelines on studies designed to show a new antibiotic works as well as an older one “and has requested that Pfizer provide additional data with regard to dalbavancin,” the company said.
“Pfizer is working with the FDA to respond to these new requirements,” the company said.
The FDA letter also refers to production problems at a third-party manufacturer not related to dalbavancin, Pfizer said, adding that the third party was working to resolve those issues.
Pfizer said it also was addressing an FDA question regarding storage time for dalbavancin.
Dalbavancin is a once-weekly, two-dose antibiotic that Pfizer acquired when it bought Vicuron Pharmaceuticals in 2005. (Reporting by Lisa Richwine, editing by Leslie Gevirtz, Richard Chang)