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 215344) for Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) for oral solution. The application cannot be approved in its current state due to several identified deficiencies.Primary issues include unresolved product quality and manufacturing facility deficiencies observed during a recent inspection. The company must also revise the proposed prescribing information (labeling) to conform with regulatory content and format requirements (21 CFR 201.56(a), (d), and 201.57), submitting it in Structured Product Labeling (SPL) format. Updates to carton and container labeling are also required.Braintree Laboratories is instructed to resubmit the proposed proprietary name, Suflave, when addressing other deficiencies. A comprehensive safety update, in accordance with 21 CFR 314.50(d)(5)(vi)(b), is mandatory, requiring new clinical and nonclinical data, detailed changes in the safety profile, comparisons of adverse event frequencies, updated exposure information, and a summary of worldwide safety experience.The company has one year to provide a complete response addressing all deficiencies. Failure to do so may result in the application's withdrawal. The drug cannot be legally marketed without written FDA approval.