Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial
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The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for ALIQOPA (copanlisib) for injection, 60 milligrams (mg)/vial, held by Bayer HealthCare Pharmaceuticals Inc., 100 Bayer Blvd., Whippany, NJ 07981- 0915. Bayer HealthCare Pharmaceuticals Inc. (Bayer) has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Abstract as published in the Federal Register.
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