Biogen, Inc. · thư phản hồi hoàn chỉnh (NDA 209531/S-016)

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‘4 ¢ BN U.S. FOOD & DRUG ADMINISTRATION NDA 209531/S-016 THƯ PHẢN HỒI HOÀN CHỈNH Biogen, Inc. Attention: Charlene Wheeler, MSHS Director, Global Regulatory Sciences 225 Binney Street Cambridge, MA 02142 Dear Charlene Wheeler: Please refer to your su mental new drug application (SNDA) for Spinraza (nusinersen) injection. This “Prior Approval” efficacy supplement to your application proposes revisions throughout the Prescribing Information (PI) regarding a completed clinical study [Study 4 (NCT04089566)] to provide support for inclusion of an additional higher dosing regimen. Two corresponding additional strength presentations [28 mg/5 mL (5.6 mg/mL) and 50 mg/5 mL (10 mg/mL)] were proposed for administration of the new dosing regimen. This sNDA also proposes revisions to the Pediatri

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