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Results For "FDA"

1767 News Found

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 Lenalidomide Capsules
Drug Approval | September 15, 2022

Zydus receives final approval from USFDA for Lenalidomide Capsules

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


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


Panacea Biotec received US FDA communication for Baddi facility
Drug Approval | September 09, 2022

Panacea Biotec received US FDA communication for Baddi facility

The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved


Cipla receives US FDA approval for Revlimid (Lenalidomide) capsules
Drug Approval | September 08, 2022

Cipla receives US FDA approval for Revlimid (Lenalidomide) capsules

Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings


USFDA approves first treatment option for generalized pustular psoriasis flares in adults
Drug Approval | September 03, 2022

USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares


Zydus receives final approval from USFDA for two tablets
Drug Approval | September 01, 2022

Zydus receives final approval from USFDA for two tablets

The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04


US FDA issues 17 observations for Biocon Biologics sites
News | September 01, 2022

US FDA issues 17 observations for Biocon Biologics sites

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | September 01, 2022

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise