Caplin Steriles Secures USFDA Approval for Generic Methylprednisolone Injection
New Delhi: Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL and 80 mg/mL, in single-dose vials.
The approved product is a generic version of Pfizer Inc.’s reference listed drug Depo-Medrol. Methylprednisolone Acetate Injectable Suspension is a corticosteroid indicated for its anti-inflammatory effects and is used in the management of various conditions, including allergic disorders, dermatological diseases, endocrine and gastrointestinal disorders, hematologic conditions, ophthalmic diseases, respiratory illnesses, and rheumatic disorders.
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