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Results For "bioequivalent"

158 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.


Lupin launches generic Brivaracetam oral solution in US to treat epilepsy
News | February 25, 2026

Lupin launches generic Brivaracetam oral solution in US to treat epilepsy

Brivaracetam is the bioequivalent to Briviact Oral Solution, 10 mg/mL, of UCB


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


Lupin launches Topiramate ER capsules in US
News | February 05, 2026

Lupin launches Topiramate ER capsules in US

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals


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


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


Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial
News | December 12, 2025

Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial

Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug


Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe
News | December 12, 2025

Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe

This is the first approval of a prescription transdermal dosage Form in the European markets from this facility