Incompatibility of drug product with proposed vials and incomplete data for alternative vials
Severity: criticalThe drug product solution is incompatible with the proposed commercial borosilicate glass vials. Data provided for alternative aluminosilicate glass vials are incomplete and ambiguous, with glass particles found in clinical batches. A comprehensive study report with unambiguous data and fully validated methods is required to demonstrate compatibility with the proposed primary container closure system.
Recommended response: Conduct comprehensive compatibility studies with unambiguous data and fully validated methods for the proposed primary container closure system.
Incomplete Container Closure Integrity Testing (CCIT) data for aluminosilicate vials
Severity: majorThe information request response regarding CCIT performed with aluminosilicate vials (batches GB2007B, GB2008B, GB2009B) is incomplete. Additional information is needed, including spectrophotometric data from dye ingress studies, details of the CCIT protocol, confirmation of worst-case condition exposure, and confirmation of pressure and vacuum conditions during testing. A new CCIT may be required if these conditions were not met.
Recommended response: Provide complete spectrophotometric data for CCIT dye ingress studies, detailed CCIT protocol, and confirm worst-case condition exposure and pressure/vacuum application during testing, or conduct a new CCIT.
Labeling comments reserved pending application adequacy
Severity: minorComments on the proposed labeling are reserved until the application is otherwise adequate. The sponsor is encouraged to review labeling review resources, regulations, and guidance documents, including the Selected Requirements for Prescribing Information (SRPI) checklist. An updated content of labeling in structured product labeling (SPL) format is required with the resubmission.
Recommended response: Review labeling resources and guidance, use the SRPI checklist, and submit updated content of labeling in SPL format with the resubmission.
Cited: 21 CFR 314.50(l)(1)(i)
Resubmit proposed proprietary name with application deficiencies
Severity: infoThe proposed proprietary name, Sunlenca, was found acceptable pending approval of the application. It needs to be resubmitted when responding to the application deficiencies.
Recommended response: Resubmit the proposed proprietary name (Sunlenca) as part of the complete response.
Comprehensive safety update required
Severity: majorA comprehensive safety update, as described at 21 CFR 314.50(d)(5)(vi)(b), is required with the response to deficiencies. This includes data from all nonclinical and clinical studies, significant changes in safety profile, new safety data tabulations, comparisons, case reports for deaths/SAEs, updated exposure information, and worldwide experience.
Recommended response: Prepare a comprehensive safety update including all nonclinical and clinical data, significant changes, new safety data tabulations, comparisons, case reports for deaths/SAEs, updated exposure information, and worldwide experience, as per 21 CFR 314.50(d)(5)(vi)(b).
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Approval of lenacapavir tablet contingent on lenacapavir injection approval
Severity: criticalDeficiencies in the product quality information for lenacapavir injection (NDA 215973) must be adequately addressed before the lenacapavir tablet application (NDA 215974) can be approved. A letter of authorization identifying the date of the Complete Response submission for NDA 215973 is required.
Recommended response: Address all deficiencies for lenacapavir injection (NDA 215973) and submit a letter of authorization for the tablet NDA (215974) confirming the injection's complete response submission date.
