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New Drug Application (NDA) - Articles and news items

Daiichi Sankyo logo

Daiichi Sankyo and Daiichi Sankyo Espha submit supplemental New Drug Application in Japan for “Cravit® Tablets, Granules” and “Levofloxacin Tablets, Granules DSEP”

Industry news / 1 October 2014 / Daiichi Sankyo

Daiichi Sankyo Company Limited announced that it and its domestic generic subsidiary, Daiichi Sankyo Espha Co., Ltd. have submitted a supplemental New Drug Application (sNDA) in Japan…

TEVA LOGO

Teva announces FDA acceptance of NDA filing for investigational short-acting beta-agonist inhaler (Albuterol MDPI)

Industry news / 14 July 2014 / Teva

First breath-actuated dry-powder SABA inhaler to be accepted by FDA for review…

Janssen Pharmaceuticals Logo

Supplemental New Drug Applications for once-monthly long-acting therapy INVEGA® SUSTENNA® submitted to the U.S. FDA for the treatment of schizoaffective disorder

Industry news / 14 May 2014 / Johnson & Johnson

Janssen Pharmaceuticals, Inc., announced the submission of supplemental New Drug Applications for once-monthly atypical long-acting antipsychotic INVEGA® SUSTENNA® (paliperidone palmitate) to the U.S. Food and Drug Administration…

Daiichi Sankyo logo

Daiichi Sankyo submits SAVAYSA(TM) (edoxaban) tablets New Drug Application to the U.S. FDA

Industry news / 9 January 2014 / Daiichi Sankyo

Submission based on the two largest comparative phase 3 clinical trials of a novel oral anticoagulant in patients with non-valvular atrial fibrillation or symptomatic venous thromboembolism…

Daiichi Sankyo logo

Daiichi Sankyo submits supplemental New Drug Application in Japan for LIXIANA® (Edoxaban Tosilate Hydrate) for new indications

Industry news / 19 December 2013 / Daiichi Sankyo Company

Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation (AF) and symptomatic venous thromboembolism…

Article 3: The implementation of rapid microbiological methods

Article 3: The implementation of rapid microbiological methods

Issue 3 2010, Microbiology / RMMs, Past issues / 24 June 2010 / Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC

This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorisation.

 

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