Vyluma Discusses Response to FDA’s Questions and Clarifies Regulatory Pathway for its 505(b)(2) NDA, NVK002 to slow the progression of myopia in children.
Enforcement Report - Week of January 24, 2024
Mankind`s Generic Atropine Sulfate Receives Approval in the U.S.
Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter
Medefil Announces Availability of FDA-Approved Emergency Syringes
Enforcement Report - Week of June 7, 2023
Enforcement Report - Week of February 15, 2023
Enforcement Report - Week of February 1, 2023
Medefil's Generic Atropine Sulfate Receives Approval in the U.S.
Amneal launches 4 new Generic products, including Vasopressin single-dose