Drug Approval | September 22, 2022
Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets
The ANDA was filed as 'First to File' submission on NCE-1 date.
The ANDA was filed as 'First to File' submission on NCE-1 date.
Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (RLD Suprep Bowel Prep Kit) had estimated annual sales of US $202 mn in the US
Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.
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
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
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