Drug Approval | September 17, 2025
FDA approves Lupin’s Lenalidomide capsules
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million
Rivaroxaban is used to treat venous thromboembolism
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
Glucagon is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of steroidresponsive inflammatory conditions of the palpebral and bulbar conjunctiva
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