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Results For "Zydus-Pharmaceuticals"

20 News Found

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


Zydus Cadila receives tentative approval for IBS tablets
Drug Approval | November 15, 2021

Zydus Cadila receives tentative approval for IBS tablets

The group now has 324 approvals and has so far filed over 400 ANDAs


Zydus Cadila receives final approval for Apremilast
Drug Approval | September 24, 2021

Zydus Cadila receives final approval for Apremilast

Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy


Zydus ties up with CHEMI to launch Enoxaparin Sodium injection in the US
Drug Approval | August 20, 2021

Zydus ties up with CHEMI to launch Enoxaparin Sodium injection in the US

Enoxaparin Sodium Injection, USP is used for prophylaxis of Deep Vein Thrombosis (DVT) in patients undergoing abdominal, hip or knee replacement surgery, and also for the treatment of acute DVT