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Results For "therapeutically-equivalent"

190 News Found

Glenmark Pharmaceuticals USA to launch sodium phosphates injection
News | February 28, 2026

Glenmark Pharmaceuticals USA to launch sodium phosphates injection

The product addresses a market with approximately $66.8 million in annual sales as of December 2025.


Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%
Drug Approval | February 25, 2026

Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%

Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.


Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL
Drug Approval | February 25, 2026

Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL

Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older


Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets
Drug Approval | February 07, 2026

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets


Indoco Remedies bags USFDA nod for Lacosamide oral solution
News | February 02, 2026

Indoco Remedies bags USFDA nod for Lacosamide oral solution

The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa


Briefs: Medicamen Biotech and Gland Pharma
Drug Approval | January 08, 2026

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)


Glenmark Pharmaceuticals USA launches Epinephrine Injection USP, multiple-dose vial
News | December 23, 2025

Glenmark Pharmaceuticals USA launches Epinephrine Injection USP, multiple-dose vial

According to IQVIA sales data for the 12-month period ending October 2025, the Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) market2 achieved annual sales of approximately $67.6 million