Article: FDA to review New Drug Application for Oracea.(PIPELINE PREVIEWS)

Article: Able Laboratories Receives its First FDA New Drug ...
Business Wire;  June 26, 2001 ;     700+ words ... ... OTCBB:ABRX), today announced it has received Food and Drug Administration (FDA) approval for its first-ever New Drug Application (NDA) for its unique product for the treatment of urinary tract infections (UTIs). It is the first branded ...

Article: SciClone Announces Positive Data from Phase 3 Hepatitis B Trial ...
Business Wire;  June 25, 2003 ;     700+ words ... ... marketing and regulatory efforts." SciClone has begun the preparation process for the JNDA, or Japanese New Drug Application. The new drug approval process in Japan involves many levels of review by the Japanese Ministry of Health before safety ...

Article: Advanced Magnetics announces filing of investigational new ...
PR Newswire;  August 11, 1987 ;     546 words ... ... MAGNETICS ANNOUNCES FILING OF INVESTIGATIONAL NEW DRUG APPLICATION WITH THE FDATIGATIONAL NEW DRUG CAMBRIDGE, Mass., Aug. 11 /PRNewswire ... that it had filed its first Investigational New Drug (IND) applications. The new diagnostic ...

Article: Forest/Cypress submit NDA for milnacipram.(New Drug ...
Pharma Marketletter;  March 3, 2008 ;     700+ words ... ... and fellow USA-based Cypress Bioscience say that the Food and Drug Administration has accepted for review their New Drug Application for milnacipran for the treatment of fibromyalgia. With a standard 10-month review timeline, a decision is ...

Article: Vicuron Pharmaceuticals Submits New Drug ...
PR Newswire;  December 21, 2004 ;     700+ words ... ... today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug ... that the timing of the filing of any new drug application or any amendment to a new drug application might be delayed, that clinical trials ...

Article: Vicuron Pharmaceuticals Files Amendment to Anidulafungin ...
PR Newswire;  May 31, 2005 ;     700+ words ... ... amendment to its existing anidulafungin New Drug Application (NDA) with the U.S. Food and Drug ... that the timing of the filing of any new drug application or any amendment to a new drug application might be delayed, that clinical trials ...

Article: Vicuron Pharmaceuticals Files New Drug ...
PR Newswire;  August 18, 2005 ;     700+ words ... ... MICU) announced today it filed a New Drug Application (NDA) with the U.S. Food and Drug ... that the timing of the filing of any new drug application or any amendment to a new drug application might be delayed, that clinical trials ...