Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
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.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.