Media is reporting that BTG’s Phase IIa study of a novel gel formulation of paxclitaxel showed tumor reduction in 70% of patients. In effect, BTG is taking a known agent and directly targeting the affected tissues; BTG is also reportedly in later phase trials looking at this gel product in brain cancer - placing the [...]
Archive for April, 2009
505(b)(2) Program: BTG’s Paxclitaxel Gel for Oesophageal Cancer
Published April 17th, 2009 in News Commentary. 0 CommentsFDA announced on April 9 that it had approved Sciele Pharma’s benzyl alcohol lotion, 5% for the first-line treatment of head lice. Sciele was recently acquired by Shionogi Company.
Sciele licensed this product in July 2007 from Summers Laboratories. The product had a PDUFA date of April 2008 but closure issues led to a revised date [...]
Morphine Solution - FDA Changes its decision
Published April 13th, 2009 in News Commentary. 0 CommentsWe recently discussed FDA’s decision to remove morphine-containing products from the market. Unfortunately, this decision was made without the benefit of an NDA-approved product being available. This left a void in the market - no oral morphine solution was available for home care. Give some credit to the FDA - they swiftly reversed their decision [...]
Yesterday, 3/31//09, FDA sent warning letters to nine pharmaceutical companies to stop manufacturing 14 unapproved narcotic drugs. These drugs are unapproved because they were made without NDA or ANDA approvals, falling under the category of DESI or grandfathered drugs.
Warning letters were sent to the following companies (I have listed the affected drug products for each [...]
DESI + non-cGMP = Recall
Published April 22nd, 2009 in News Commentary. 0 CommentsFDA is clamping down on DESI’s, but to date we have seen FDA only stop manufacturing and distibution. Until now. On April 20, 2009, Neilgen Pharmaceuticals and its parent Advent Pharmaceuticals were forced into a recall of 13 cough/cold medications. All of the cough cold medications are tannate salts of common ingredients. It is one [...]