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Results For "Zydus-Pharmaceuticals"

23 News Found

Zydus launches Topiramate Extended-Release Capsules
Drug Approval | January 07, 2023

Zydus launches Topiramate Extended-Release Capsules

Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.


Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection
Drug Approval | November 29, 2022

Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection

The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India


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 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 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


Zydus receives final approval from USFDA for Cariprazine Capsules
Drug Approval | September 15, 2022

Zydus receives final approval from USFDA for Cariprazine Capsules

Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder


Zydus gets 180 days of shared exclusivity for Roflumilast tablets
Drug Approval | February 14, 2022

Zydus gets 180 days of shared exclusivity for Roflumilast tablets

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad


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