J&J Drug Gets Mixed Panel Vote - TheStreet

J&J Drug Gets Mixed Panel Vote

The drugmaker is seeking FDA approval for expanded use of Doribax, as treatment for hospital-acquired pneumonia.
Author:
Publish date:

A panel of experts deemed

Johnson & Johnson's

(JNJ) - Get Report

Doribax safe and effective Wednesday, but their voting revealed they weren't too keen on accepting the studies that support the drug's application for Food and Drug Administration approval.

The advisory panel voted 7-to-6 that the injected antibiotic is effective for treating hospital-acquired pneumonia and 8-to-5 that Doribax was safe for the indication. However, the panel also voted 9-to-4 against accepting studies submitted in support of the company's filing.

The FDA is expected to soon make a decision on the drug, which is already approved for complicated inner-abdomen and urinary tract infections. The agency isn't obligated to follow the recommendations of its advisory panels, but it typically does.

Shares of the New Brunswick, N.J.-based drugmaker closed Wednesday up 49 cents, or 0.7%, at $68.19.