# FDA CRL - Hikma Pharmaceuticals USA, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/crl/hikma-pharmaceuticals-usa-inc/81aa8665-2173-4b06-b9bc-9106fb4e67ac

> FDA CRL for Hikma Pharmaceuticals USA, Inc. on Unknown Date. Product: NDA (New Drug Application). Access full analysis and detailed observations.

---

## Details

- Record Type: CRL
- Company Name: Hikma Pharmaceuticals USA, Inc.
- Product Type: NDA (New Drug Application)
- Summary: 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 

## Related Officers

- [Amy Schutte](https://www.globalkeysolutions.net/people/amy-schutte/6b00b68f-b7c8-4713-bbad-d6316a44e822)

Company: https://www.globalkeysolutions.net/companies/hikma-pharmaceuticals-usa-inc/f0f0db3f-c818-4402-a2c9-858a3171c8b2