WOBURN, Mass., May 6, 2024 /PRNewswire/ -- Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Myhibbin™, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body's immune response. In 2023, there were over 46,000 transplants in the US and these patients need to take medication every day to fight against rejection. Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
Enforcement Report - Week of February 7, 2024
Azurity Pharmaceuticals is recalling one batch of Zenzedi 30mg tablets from U.S. shelves after it received a report from a pharmacist in Nebraska who opened a bottle of the narcolepsy treatment and instead found carbinoxamine maleate, an antihistamine drug.
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing
Enforcement Report - Week of January 10, 2024
Enforcement Report - Week of April 12, 2023
MIAMI, Sept. 7, 2022 /PRNewswire/ -- Brand Institute is proud to announce its work with Azurity Pharmaceuticals (formerly CutisPharma) in developing the brand name KONVOMEP™, which was approved by the FDA on August 30, 2022.
Massachusetts-based Azurity Pharmaceuticals has been doing well this year in getting its products past FDA approval, and the company is looking to continue that trend Friday.
The company plans to make Konvomep available commercially in the US by the first quarter of next year.