Complete Response Letters
ViiV Healthcare Company: CABENUVA®
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Dec 19, 2019
Drug, and Cosmetic Act for VOCABRIA® (cabotegravir) 30 mg tablets.
CRL_NDA212887_20191219:p1:s12VOCABRIA (cabotegravir) NDA is contingent on the approval of the CABENUVA NDA, the CABENUVA NDA deficiencies must be adequately addressed before this application can be approved.
CRL_NDA212887_20191219:p1:s17Complete Response Letter, Dec 19, 2019
Drug, and Cosmetic Act for CABENUVA® (cabotegravir extended release injectable suspension + rilpivirine extended release injectable suspension) 600 mg/900 mg copack.
CRL_NDA212888_20191219:p1:s12We also acknowledge receipt of your amendment dated December 17, 2019. A formal review of this amendment is deferred to the next review cycle.
CRL_NDA212888_20191219:p1:s13Note that as a follow-up to the pre-approval inspection, a Post-Action Memorandum with outstanding concerns will be sent to the inspected drug product facility.
CRL_NDA212888_20191219:p1:s21Ensure that a future resubmission includes updates to the relevant modules of application in response to these deficiencies.
CRL_NDA212888_20191219:p1:s22DMF holder on December 18, 2019. These deficiencies must be adequately addressed before this application can be approved.
CRL_NDA212888_20191219:p1:s26More Complete Response Letters
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