Dr. Reddy’s gets tentative FDA approval for generic Zenavod

SILVER SPRING, Md. — The Food and Drug Administration on Monday gave tentative approval to Dr. Reddy’s Laboratories’ generic version of Zenavod (doxycycline) capsules. 

 

The drug is intended to treat inflammatory lesions of rosacea in adults and will be available in 40-mg capsules once it is given final approval. 

 

The approval is tentative due to an ongoing patent infringement process under the Drug Price Competition and Patent Term Restoration Act, the company said. The drug has met agency’s safety, quality and efficacy standards. 

 

“We are pleased to receive a tentative FDA approval of Zenavod and will be working with external parties and the FDA to gain a full approval,” Dr. Reddy's CEO and co-chairman G.V. Prasad said.