FDA CRL - Braintree Laboratories, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Braintree Laboratories, Inc. concerning their New Drug Application (NDA 213135) for SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. The FDA determined that the application could not be approved in its present form, citing several issues under the Federal Food, Drug, and Cosmetic Act, section 505(b)(2).

A primary issue identified was deficiencies found during a recent inspection of Braintree Laboratories' manufacturing facility in Massachusetts. Satisfactory resolution of these product quality and facility-related issues is required before the NDA can be approved. Additionally, the FDA reserved comment on the proposed prescribing information, pending resolution of other issues, and requested updated draft carton and container labeling. The proposed proprietary name, SUTAB, was found acceptable but must be resubmitted once other deficiencies are addressed.

Braintree Laboratories must also provide a comprehensive safety update, as outlined in 21 CFR 314.50(d)(5)(vi)(b). This update requires detailed reporting of any significant changes in the safety profile, retabulation of adverse event frequencies, case report forms for patient deaths or serious adverse events, updated exposure information, and a summary of worldwide safety experience for the drug.

The company is required to fully address all listed deficiencies and resubmit the application within one year, clearly marking it as a "RESUBMISSION." The drug may not be legally marketed until written approval is received.