Takeda Global Research & Development Centre Inc, a subsidiary of Takeda Pharmaceutical Company Limited, has announced today that it has resubmitted New Drug Applications for alogliptin and fixed-dose combination alogliptin and pioglitazone to the United States Food and Drug Administration (FDA).
Pharmaceutical company Alexza Pharmaceuticals Inc (NasdaqGM:ALXA) reported on Thursday the acceptance of its resubmitted ADASUVE New Drug Application (NDA) by the US Food & Drug Administration (FDA) in response to its action letter.
28 December 2011 - Japan's Eisai Co Ltd (TYO:4523) said on Monday it had recently resubmitted the New Drug Application (NDA) for the investigational AMPA receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the US Food and Drug Administration (FDA).
The FDA meeting minutes said the resubmission will be designated as "Class 2," which suggests the resubmitted application will be reviewed within six months of receipt.
Zogenix does not expect the rescission of Breakthrough Therapy Designation to limit the potential for Priority Review status for the Company's resubmitted NDA.
Sandoz, a Novartis division and a company involved in biosimilars, announced yesterday that it has resubmitted its Biologics License Application (BLA) for a proposed biosimilar Pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016.