June 22, 2020 / 1:04 PM / 16 days ago

BRIEF-FDA Accepts Supplemental Biologics License Application For Botox

June 22 (Reuters) - Abbvie Inc:

* FDA ACCEPTS SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION (SBLA) FOR BOTOX® (ONABOTULINUMTOXINA) FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY

* ABBVIE INC - PRESCRIPTION DRUG USER FEE ACT DATE IS EXPECTED TO BE IN Q1 OF 2021 FOLLOWING A STANDARD 10-MONTH REVIEW.

* ABBVIE - SBLA IS BASED ON DATA FROM A RANDOMIZED, DOUBLE-BLIND PHASE 3 STUDY EVALUATING SAFETY AND EFFICACY OF BOTOXIN MORE THAN 100 PEDIATRIC PATIENTS Source text for Eikon: Further company coverage:

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