FDA gives tentative approval to Roxane pneumonia drug

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

According to the FDA's website, the agency granted the preliminary authorization for Roxane Labs' linezolid oral suspension in the 100-mg-per-5-mL strength.

The drug is a generic version of Pfizer's Zyvox. Tentative approval means that the product meets the FDA's requirements for approval, but the agency can't approve it until patents covering the branded version expire; the first patent on the drug will expire in 2014.