Issued January 1, 2018
Issued
January 1, 2018
Application
Other • 208647
Review center
Other
Stage
Final Decision
Letter type
Approval Letter
This document is a Complete Response letter from the FDA to Salamandra, LLC regarding New Drug Application (NDA) 208647 for rosuvastatin capsules. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name, and safety update requirements.
The application received a Complete Response due to unresolved manufacturing facility deficiencies, pending review of proposed labeling, the need to resubmit the proprietary name, and a requirement for a comprehensive safety update encompassing all nonclinical and clinical data, worldwide experience, and foreign labeling translations.
During a recent inspection of Sun Pharmaceutical Industries Limited, Halol-Baroda 389350, Gujarat, India, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved.
Recommended response: Address all deficiencies identified during the facility inspection and ensure satisfactory resolution with the agency.
The agency reserves comment on the proposed labeling until the application is otherwise adequate. The applicant is encouraged to review PLR Requirements for Prescribing Information, Pregnancy and Lactation Labeling Final Rule, and the Selected Requirements for Prescribing Information (SRPI) checklist. Any revised labeling must conform to format items in regulations and guidances and include updated content of labeling in structured product labeling (SPL) format.
Recommended response: Revise labeling according to PLR requirements, Pregnancy and Lactation Labeling Final Rule, and SRPI checklist. Submit updated content in SPL format.
Cited: 21 CFR 314.50(l)(1)(i)
The proposed proprietary name, Ezallor, was found acceptable pending approval of the application in the current review cycle. The applicant must resubmit the proposed proprietary name when responding to the application deficiencies.
Recommended response: Resubmit the proposed proprietary name 'Ezallor' with the complete response.
A comprehensive safety update is required as described at 21 CFR 314.50(d)(5)(vi)(b). This update must include data from all nonclinical and clinical studies/trials, regardless of indication, dosage form, or dose level. Specific requirements include: describing significant changes in safety profile; presenting new safety data from studies/clinical trials for the proposed indication; presenting tabulations of new safety data combined with original NDA data; including tables comparing frequencies of adverse events; providing separate tables for adverse events in clinical trials for other indications; retabulating reasons for premature trial discontinuation; providing case report forms and narrative summaries for patient deaths or discontinuations due to adverse events, and for serious adverse events; describing information suggesting substantial change in incidence of common, less serious adverse events; providing updated exposure information for clinical studies/trials; providing a summary of worldwide experience on drug safety, including updated estimate of use for marketed drugs in other countries; and providing English translations of current approved foreign labeling not previously submitted.
Recommended response: Compile and submit a comprehensive safety update as per 21 CFR 314.50(d)(5)(vi)(b), including all requested clinical and nonclinical data, worldwide experience, and foreign labeling translations.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
The application was not approved due to critical manufacturing site deficiencies, pending labeling review, and the need for a comprehensive safety update covering clinical, nonclinical, and global safety data.
Regulatory change impact: Pending sponsor mitigation plan
Approval likelihood after response: 5%
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