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Results For "U.S.-FDA"

246 News Found

Lupin launches Mirabegron ER tablets in US
Drug Approval | September 04, 2024

Lupin launches Mirabegron ER tablets in US

Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development


Lupin launches Doxorubicin Hydrochloride Liposome Injection in US
Drug Approval | September 03, 2024

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US

ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA


Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan
News | August 30, 2024

Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan

Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025


Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%
Drug Approval | August 28, 2024

Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%

Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Aptar’s nasal unidose system delivers FDA-approved neffy
News | August 19, 2024

Aptar’s nasal unidose system delivers FDA-approved neffy

This marks the first regulatory approval worldwide for nasally-delivered epinephrine


Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution
Drug Approval | August 17, 2024

Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.


Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr
News | August 10, 2024

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr

This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.


Lupin completes  successful Phase 3 trials for Lucentis biosimilar
Biotech | August 06, 2024

Lupin completes successful Phase 3 trials for Lucentis biosimilar

The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU


Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP
News | August 06, 2024

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity


Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets
Drug Approval | August 01, 2024

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries