Meitheal Pharmaceuticals Announces FDA Approval of Garzulys™ (insulin aspart-fsan) Injection
FDA approves Garzulys™ (insulin aspart-fsan), a rapid-acting insulin analog to improve glycemic control in adults and pediatric patients with diabetes mellitus
Meitheal serves as the U.S. Regulatory Agent for Garzulys and holds exclusive U.S. commercialization rights under its license agreement with Emerge, the BLA holder
Approval marks an important milestone in Meitheal’s continued expansion into complex biologics and essential medicines
Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines, biologics, fertility products and branded medicines, today announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys™ (insulin aspart-fsan) injection, a biosimilar to NovoLog® (insulin aspart). Emerge Bioscience Pte. Ltd. (“Emerge”) is the holder of the approved Biologics License Application (BLA) for Garzulys. Meitheal serves as the product’s U.S. Regulatory Agent and holds exclusive U.S. commercialization rights under its license agreement with Emerge.
