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Results For "USFDA"

1316 News Found

Biocon Pharma receives USFDA approval for daptomycin
Drug Approval | September 01, 2024

Biocon Pharma receives USFDA approval for daptomycin

The approval further adds to Biocon’s portfolio of complex drug products


Zydus receives warning letter from USFDA for Jarod injectables manufacturing facility
Drug Approval | August 31, 2024

Zydus receives warning letter from USFDA for Jarod injectables manufacturing facility

The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility


Natco Pharma announces submission of TABRECTA to USFDA
Drug Approval | August 30, 2024

Natco Pharma announces submission of TABRECTA to USFDA

TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA


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


Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg
Drug Approval | August 28, 2024

Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg

Also received tentative approval for 137 mg


Shilpa Medicare receives USFDA approval for Bortezomib injection
Drug Approval | August 27, 2024

Shilpa Medicare receives USFDA approval for Bortezomib injection

Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)


Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg
Drug Approval | August 21, 2024

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India


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.