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Results For "Zydus-Lifesciences-Limited"

96 News Found

Zydus receives final approval from USFDA for Micafungin for Injection
Drug Approval | October 26, 2022

Zydus receives final approval from USFDA for Micafungin for Injection

Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data


Zydus receives tentative approval from USFDA for Roflumilast tablets
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Roflumilast tablets

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data


Zydus receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data


Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets
Drug Approval | October 07, 2022

Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.


Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules
Drug Approval | October 05, 2022

Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules

Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data


Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets
Drug Approval | October 04, 2022

Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency


Zydus receives final approval from the USFDA for Sildenafil for Oral Suspension
Drug Approval | October 01, 2022

Zydus receives final approval from the USFDA for Sildenafil for Oral Suspension

Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).


USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility
Drug Approval | September 30, 2022

USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility

The company will address the observations within a stipulated timeline working with the regulators


Zydus launches Lenalidomide Capsules
News | September 22, 2022

Zydus launches Lenalidomide Capsules

Lenalidomide is used to treat various types of cancers.


Zydus receives tentative approval from USFDA for Sugammadex Injection
Drug Approval | September 19, 2022

Zydus receives tentative approval from USFDA for Sugammadex Injection

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery