Issued to King Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 15, 2009Application
NDA 505b1 • 022377
Product
ALSUMA
Company
King Pharmaceuticals, Inc.
Stage
Final Decision
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to King Pharmaceuticals, Inc. on May 15, 2009.
NDA 022377 is the application under which FDA issued this complete response letter for ALSUMA to King Pharmaceuticals, Inc.. The letter is dated May 15, 2009.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.