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Results For "Competitive-Generic-Therapy"

11 News Found

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation
Drug Approval | August 03, 2023

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation

Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.


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


Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
Drug Approval | October 02, 2024

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25


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 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


Strides receives USFDA approval for Ibuprofen OTC oral suspension
Drug Approval | June 12, 2022

Strides receives USFDA approval for Ibuprofen OTC oral suspension

Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.


USFDA approves first generic version of Apokyn cartridges
Drug Approval | March 02, 2022

USFDA approves first generic version of Apokyn cartridges

TruPharma has commenced commercial marketing of Sage's approved generic cartridge product


Amneal expands injectables portfolio with four new products
Drug Approval | February 19, 2022

Amneal expands injectables portfolio with four new products

Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market


Sun gets US FDA approval for generic amphotericin B injection
Drug Approval | December 16, 2021

Sun gets US FDA approval for generic amphotericin B injection

It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity


Zydus Cadila receives U.S.FDA approval for leukaemia injection
Drug Approval | November 18, 2021

Zydus Cadila receives U.S.FDA approval for leukaemia injection

Nelarabine is in a class of medications called antimetabolites