Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL and 80 mg/mL Single-Dose Vials and 200 mg/5 mL (40 mg/mL), 400 mg/10 mL (40 mg/mL), and 400 mg/5 mL (80 mg/mL) Multiple-Dose Vials. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Medrol Injectable Suspension, 40 mg/mL and 80 mg/mL, of Pfizer Inc.
The Product is indicated for the treatment of Allergic States, Dermatologic Diseases, Endocrine Disorders, Gastrointestinal Diseases, Hematologic Disorders, Neoplastic Diseases, Nervous System, Ophthalmic Diseases, Renal Diseases, Respiratory Diseases, Rheumatic Disorders and Miscellaneous. According to IQVIA, the Methylprednisolone injection had US sales of approximately $214 million for the twelve months ending August 2026.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
