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FDA accepts regulatory submission for Lynparza in metastatic breast cancer
Lynparza has the potential to offer a new treatment option for patients with metastatic breast cancer...
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New Drug Application (NDA)
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Daiichi Sankyo and Daiichi Sankyo Espha submit supplemental New Drug Application in Japan for “Cravit® Tablets, Granules” and “Levofloxacin Tablets, Granules DSEP”
1 October 2014 | By 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...
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Teva announces FDA acceptance of NDA filing for investigational short-acting beta-agonist inhaler (Albuterol MDPI)
14 July 2014 | By Teva
First breath-actuated dry-powder SABA inhaler to be accepted by FDA for review...
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Supplemental New Drug Applications for once-monthly long-acting therapy INVEGA® SUSTENNA® submitted to the U.S. FDA for the treatment of schizoaffective disorder
14 May 2014 | By 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...
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Daiichi Sankyo submits SAVAYSA(TM) (edoxaban) tablets New Drug Application to the U.S. FDA
9 January 2014 | By 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...
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Daiichi Sankyo submits supplemental New Drug Application in Japan for LIXIANA® (Edoxaban Tosilate Hydrate) for new indications
19 December 2013 | By 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
Article 3: The implementation of rapid microbiological methods
24 June 2010 | By 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…
