Pfizer withdraws dalbavancin app

Pfizer has withdrawn U.S. and European marketing applications for dalbavancin--a drug for complicated skin and skin structure infections in adults--following feedback from regulatory agencies. The company now plans on conducting another Phase III trial of the drug on infections caused by Gram-positive bacteria, including MRSA. Pfizer will also start a pediatric program for the drug.

"After careful consideration of feedback and ongoing dialogue with regulatory authorities, Pfizer has decided to study dalbavancin further in patients with complicated skin and skin structure infections," said Dr. Mark Kunkel, Pfizer's Global Medical Therapeutic Area Leader for Anti-infectives and HIV. Pfizer acquired dalbavancin when it bought out Vicuron Pharmaceuticals in 2005.

- check out this release for more

Suggested Articles

The FDA sent Eton's partner, Bausch Health, a complete response letter that raised “no concerns” about the clinical data in the drug’s application.

A new partnership will test drug cocktails containing Karyopharm's new product Xpovio in cell samples from glioblastoma patients.

Boehringer signed a deal to buy out a small immuno-oncology player this morning, and AbbVie’s been at it, too, inking a deal to snap up Mavupharma.