FDA CRL - Hikma Pharmaceuticals USA, Inc.

Hikma Pharmaceuticals USA, Inc. received a Complete Response Letter from the FDA for its New Drug Application (NDA 218258) for phenobarbital sodium injection, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. The FDA identified several key deficiencies preventing approval. Clinically, the application lacked analyzable efficacy and safety datasets, particularly from the