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Results For "bioequivalent"

158 News Found

Lupin receives USFDA approval for Tolvaptan Tablets
Drug Approval | April 24, 2025

Lupin receives USFDA approval for Tolvaptan Tablets

Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Eugia Pharma receives USFDA approval for Dasatinib Tablets
Drug Approval | April 24, 2025

Eugia Pharma receives USFDA approval for Dasatinib Tablets

Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia


Glenmark Pharmaceuticals USA to launch Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet
News | April 17, 2025

Glenmark Pharmaceuticals USA to launch Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet

According to IQVIATM sales data for the 12-month period ending February 2025, the Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market3 achieved annual sales of approximately $421.7 million.


Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg
Drug Approval | April 14, 2025

Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg

The product will be launched in Q1FY26


Gland Pharma receives approval for Acetaminophen Injection
Drug Approval | April 04, 2025

Gland Pharma receives approval for Acetaminophen Injection

The company expects to launch this product through its marketing partner in the near future


Glenmark Pharmaceuticals USA launches Vancomycin Hydrochloride for Injection
News | April 02, 2025

Glenmark Pharmaceuticals USA launches Vancomycin Hydrochloride for Injection

According to IQVIA sales data for the 12-month period ending January 2025, the Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial) market achieved annual sales of approximately $39.3 mn


Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%
Drug Approval | March 21, 2025

Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.


ZIM Laboratories receives marketing authorization for Dimethyl Fumarate in Portugal
News | March 20, 2025

ZIM Laboratories receives marketing authorization for Dimethyl Fumarate in Portugal

Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis


Lupin receives tentative approval from USFDA for Amifampridine Tablets
Drug Approval | March 18, 2025

Lupin receives tentative approval from USFDA for Amifampridine Tablets

Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.


Alkem launches generic empagliflozin and its combinations in India under ‘Empanorm’
News | March 13, 2025

Alkem launches generic empagliflozin and its combinations in India under ‘Empanorm’

Empagliflozin is used in the treatment of type-2 diabetes mellitus, chronic kidney disease and heart failure