NDA

(redirected from New drug application)
Also found in: Dictionary, Medical, Acronyms, Encyclopedia, Wikipedia.
Related to New drug application: abbreviated new drug application

NDA

abbreviation for NUCLEAR DECOMMISSIONING AUTHORITY.
References in periodicals archive ?
It was reported yesterday that United States-based Amicus Therapeutics is planning to file a new drug application with the United States Food and Drug Administration for the oral precision drug Migalastat intended for combating Fabry disease.
Designation as a fast track product enables Pharmaxis to file the new drug application on a rolling basis as data becomes available, allowing the FDA to review the application in sections ahead of receiving the complete submission.
Celgene, a United States-based biotechnology company, has received priority review from the US Food and Drug Administration (FDA) for its new drug application seeking approval of enasidenib intended to treat patients with relapsed/refractory acute myeloid leukaemia with isocitrate dehydrogenase 2 mutation, it was reported yesterday.
Lee previously served as Director of Pharmacokinetics with NYSE-listed, KV Pharmaceuticals, where among other duties, he coordinated and supervised the preparation of numerous applications to the FDA, including Investigational New Drug, New Drug Application, and Abbreviated New Drug Application submissions.
Relypsa, a biopharmaceutical company, has submitted a new drug application to the United States Food and Drug Administration for approval to market Patiromer for Oral Suspension (Patiromer FOS) to treat hyperkalemia, it was reported on Friday.
A Priority Review means that the time it takes FDA to review a new drug application is reduced.
Actavis plc (NYSE: ACT), a global, integrated specialty pharmaceutical company, has filed an Abbreviated New Drug Application to market Isotretinoin Capsules, 10 mg, 20 mg, 30 mg and 40 mg with the United States Food and Drug Administration, it was reported yesterday.
Gilead Sciences, a United States-based biopharmaceutical company, has submitted a new drug application for its sofosbuvir to treat patients with chronic hepatitis C virus infection to Japan's Pharmaceutical and Medical Devices Agency, it was announced yesterday.
Based on this face-to-face meeting, and summary minutes received January 26, 2007, the Company intends to file a New Drug Application (NDA) for PMI-150 as an emergency analgesic for military and civilian use in 2008.
We completed pivotal trials and filed a New Drug Application (NDA) for Zensana[TM], significantly strengthened our pipeline with four additional drug candidates, and expanded investor reach with a NASDAQ listing," stated Mark Ahn, President and CEO.
The New Drug Application submission for TOCOSOL Paclitaxel is targeted for the end of 2007.
Sonus expects data from the TOCOSOL Paclitaxel Phase 3 trial to be available in the third quarter of 2007, with submission of a New Drug Application (NDA) targeted for the end of 2007.