Several previous blogs have discussed the importance of maintaining quality oversight of a contract facility to the drug development timeline. Below is an example of a generic manufacturer with problems maintaining quality oversight of its own multiple sites. Apotex, the Canadian generic manufacturer received a CMC based warning letter on March 29th. This recent warning [...]
Archive for April, 2010
Manufacturing Problems for Intravenous Emulsions
Published April 23rd, 2010 in CMC Issues. 0 CommentsMany of the drug products manufactured by Hospira, including intravenous nutritional emulsions and propofol have been on the market for years. Hospira received a warning letter on April 12th citing two of its intravenous drug product manufacturing plants in North Carolina. The sites were inspected by the FDA in April 2009, and the violations cited [...]
In an overwhelming 19-1 vote , the FDA joint advisory committee meeting held yesterday (4/22/2010) recommended that the FDA not approve Acura/King’s proposed oxycodone + niacin tablet. As we commented on Wednesday of this week, the sponsor’s data showed that about 16% of the intended patients would experience flushing at a normal dose of oxycodone. Yet, [...]
505(b)(2): Repositioning, Repurposing or what?
Published April 20th, 2010 in 505(b)(2) Issues and Events. 0 CommentsLast week I made a presentation at the Society of Biomolecular Sciences (SBS) 2010 Annual Meeting in Phoenix (due to the Iceland volcano eruption, many participants are still there). The occasion was the inaugural meeting of the newly formed Special Interest Group for Repositioning Drugs (see the announcement of this new SIG). Dr. Chris Lipinsky [...]
On March 19 and 20th the University of Washington School of Pharmacy hosted “The Biosimilars Conference”. This conference prompted some interesting discussions. A good background of the current legal status and issues around biosimilars can be found in the September 30th blog “Biosimilars; an Introduction”. When talking about biologics it is important to remember that [...]
FDA Advisory Committee to Review Acura’s Oxycodone plus Niacin; Risk/Benefit in Question
Published April 21st, 2010 in 505(b)(2) Issues, Events and News Commentary. 2 CommentsAn FDA advisory meeting is scheduled tomorrow (4/22/2010) to review Acura Pharmaceuticals proposed Acurox® (oxycodone + niacin) immediate release tablets. Acura had submitted and NDA in December 2008 and received a Complete Response letter from FDA in June 2009 (a Complete Response letter is a denial of the approval but allowing for additional information). In [...]