FDA Approval Received by Lupin for Methylprednisolone Tablets USP

Pharma major Lupin announced that it has received approval for its Methylprednisolone Tablets USP, 2 mg, 4 mg, 8 mg, 16 mg and 32 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Pharmacia and Upjohn Company’s Medrol tablets, 2 mg, 4 mg, 8 mg, 16 mg and 32 mg.

Lupin’s Methylprednisolone Tablets USP, 2 mg, 4 mg, 8 mg, 16 mg, and 32 mg, is the generic version of Pharmacia and Upjohn Company’s Medrol Tablets, 2 mg, 4 mg, 8 mg, 16 mg and 32 mg. It is indicated to treat Endocrine Disorders, Rheumatic Disorders, Collagen Diseases, Dermatologic Diseases, Allergic States, Ophthalmic Diseases, Respiratory Diseases, Hematologic Disorders, Neoplastic Diseases, Edematous States, Gastrointestinal Diseases, Acute exacerbations of multiple sclerosis, Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, Trichinosis with neurologic or myocardial involvement.

Methylprednisolone Tablets had annual sales of approximately USD 114.3 million in the US (IQVIA MAT December 2018).

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