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396 News Found

Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL
News | December 17, 2024

Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL

According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million


Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy
Drug Approval | December 14, 2024

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months


Alembic Pharmaceuticals gets USFDA tentative approval for OTC
Drug Approval | December 05, 2024

Alembic Pharmaceuticals gets USFDA tentative approval for OTC

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander


Glenmark Pharmaceuticals USA launches Travoprost Ophthalmic Solution USP, 0.004%
News | November 28, 2024

Glenmark Pharmaceuticals USA launches Travoprost Ophthalmic Solution USP, 0.004%

Glenmark's Travoprost Ophthalmic Solution USP, 0.004% is bioequivalent and therapeutically equivalent to the reference listed drug, Travatan Z Ophthalmic Solution USP, 0.004% of Sandoz


Senores Pharmaceuticals launches Ivermectin Tablets in US with Dr. Reddy's Laboratories
News | November 28, 2024

Senores Pharmaceuticals launches Ivermectin Tablets in US with Dr. Reddy's Laboratories

The product will be marketed by Dr. Reddy's


Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets
Drug Approval | October 19, 2024

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA


Lupin launches first generic of Pred Forte in US
News | October 16, 2024

Lupin launches first generic of Pred Forte in US

Prednisolone Acetate Ophthalmic Suspension is the first generic version of Pred Forte


Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets
Drug Approval | October 04, 2024

Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets

Cetirizine is used for relief of symptoms of hay fever and other allergic conditions


USFDA inspection update on Jubilant HollisterStier’s Montreal facility
Drug Approval | September 30, 2024

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures


Alembic receives USFDA final approval for Paliperidone ER tablets
News | September 27, 2024

Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia