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Results For "approval"

2474 News Found

Lupin receives approval from USFDA for Bromfenac Ophthalmic
News | August 20, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).


Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%
Drug Approval | August 17, 2023

Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%

Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace


Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP
Drug Approval | August 16, 2023

Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).


Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma
Drug Approval | August 16, 2023

Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma

ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity


Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat
Drug Approval | August 16, 2023

Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat

Senvelgo is the first liquid once-daily, orally administered prescription medication to improve glycemic control in cats with diabetes mellitus


Eugia Pharma receives USFDA Approval for Icatibant Injection
Drug Approval | August 16, 2023

Eugia Pharma receives USFDA Approval for Icatibant Injection

This is the 166th ANDA out of Eugia Pharma Speciality Group facilities


Lupin receives USFDA approval for fluocinolone acetonide body oil
Drug Approval | August 09, 2023

Lupin receives USFDA approval for fluocinolone acetonide body oil

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)


Eugia Pharma receives USFDA approval for Vancomycin Hydrochloride for Injection USP
Drug Approval | August 06, 2023

Eugia Pharma receives USFDA approval for Vancomycin Hydrochloride for Injection USP

The product is being launched in August 2023


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.