Entreprise · 18/11/20201 min de lecture
Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications; Correction
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Résumé
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 8, 2020. The document announced the withdrawal of approval of 19 new drug applications (NDAs) from multiple applicants, withdrawn as of February 7, 2020. The document indicated that FDA was withdrawing approval of NDA 202342, Esomeprazole Strontium Delayed-Release Capsules, Equivalent to (EQ) 20 milligrams (mg) base and EQ 40 mg base, after receiving a withdrawal request from R2 Pharma, LLC, 11550 North Meridian St., Suite 290, Carmel, IN 46032-5505 (R2 Pharma). Because of clerical errors in the Agency's processing of communications regarding this application, FDA has determined that NDA 202342 remains approved. Accordingly, FDA's approval of NDA 202342 remains in effect. There are no changes with respect to the other 18 NDA withdrawals announced in the January 8, 2020 Federal Register notice.