FDA gives tentative approval to Roxane pneumonia drug

Tentative approval granted to Roxane's linezolid for oral suspension

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.

 

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