Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: FDA withdraws approval for multiple NDAs, (Jul 9, 2026)
By WK Editorial Staff
The FDA is withdrawing approval of 34 new drug applications (NDAs) from multiple applicants.
The applicants notified the FDA in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application (Notice, 91 Fed. Reg. 41045 (July 6, 2026)).
Dates. Approval is withdrawn as of August 5, 2026.
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