Drug Approval | November 08, 2025
Alembic receives FDA final approval for Sumatriptan Injection USP
Sumatriptan injection is indicated in adults for the acute treatment of migraine
Sumatriptan injection is indicated in adults for the acute treatment of migraine
Glenmark will begin distribution in November 2025
Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable
Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug Naropin Injection of Fresenius Kabi USA
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk
Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
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
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