Althera Life Sciences, LLC – FDA CRL

Althera Life Sciences, LLC received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA 213072) for rosuvastatin and ezetimibe tablet, filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The FDA determined the application could not be approved due to significant product quality and facility inspection deficiencies.

Recent inspections of two manufacturing facilities associated with the NDA revealed deficiencies requiring satisfactory resolution. Notably, testing data issues at one facility rendered the method validation information in the NDA unreliable. The FDA also identified discrepancies in manufacturing records for the 5mg/10mg strength and unsupported data limits for the 20mg/10mg strength, requiring correctional documentation and supporting data.

Required actions include revalidating analytical methods for assay, chromatographic purity, content uniformity, and dissolution using appropriate standards. Following revalidation, existing stability samples must be re-analyzed, and additional long-term stability data for various strengths provided. New drug product lots require at least six months of long-term and accelerated stability data. Althera must also update proposed labeling in Structured Product Labeling (SPL) format, resubmit the proprietary name "Roszet," and provide a comprehensive safety update as per 21 CFR 314.50(d)(5)(vi)(b). Furthermore, the company must address Pediatric Research Equity Act (PREA) requirements regarding the ezetimibe component's safety and efficacy in pediatric homozygous familial hypercholesterolemia (HoFH) for ages 1 to 17 years. Resolution of all identified deficiencies is essential for potential approval.