Today’s (9/17/08) news headlines include reporting on FDA’s ban on the import of more than 30 generic drugs made by Ranbaxy at two manufacturing sites in India. The ban is based on FDA’s adverse inspection findings (the notorious Inspectional Observations (FDA-483 form)) at Ranbaxy’s Dewas and Sahib facilities..
FDA has a wide degree of power to exclude products [...]
Archive for September, 2008
FDA Bans 30+ Ranbaxy Generic Drugs - except 1 Sole Source
Published September 17th, 2008 in News Commentary. 0 CommentsMore DESI-products cited. Exceptions are noted for unique products.
Published September 16th, 2008 in News Commentary. 0 CommentsFDA inspections and citations sometimes take a few weeks to appear on the FDA website. So, “news” is a erlative term here. Nonetheless, activity related to DESI drugs has a keen interest to us because they represent FDA thinking and potential 505(b)(2) projects.
A July 24 Warning Letter was issued by FDA to G & W Laboratories. [...]
505(b)(2) Literature Searches - Too much or too little?
Published September 15th, 2008 in 505(b)(2) Process and How to:. 0 CommentsA 505(b)(2) submission relies on information in the public domain to fulfill some of the information required in an NDA for approval. This information comes from more than the reference drug’s NDA review documents. In fact, for older drugs, the amount of information can be overwhelming. A recent Google search on an RLD yielded almost 40,000 [...]
Shionogi, a Japan-based pharmaceutical company, announced yesterday (9/1/2008) that it would buy Atlanta-based Sciele Pharma for $1.42 billion - 57% premium to the current share price. Shionogi’s analysis of the purchase is here. Sciele’s business strategy relies on 505(b)(2) drug development. Sciele in-licenses products in a wide range of therapeutic categories. Products include fenofibrate (lower doses), [...]
Transcept Pharmaceuticals (formerly TransOral) announced today (9/2/2008) that it is merging with Novacea. Transcept is a privately held company while Novacea is NASDQ-listed, so the merged company will be a public company. Novacea had 2 cancer therapies that didn’t meet expectations. Transcept has a 505(b)(2) strategy which we have reviewed in this blog before. The [...]
Another DESI in Discretion
Published September 23rd, 2008 in News Commentary. 0 CommentsEver since FDA gave notice about Marketed Unapproved Drugs, manufacturers of these drugs have been wondering when the shoe would drop on their products. Basically, the FDA has said that eventually these products must be removed from the market. Since the FDA does not have sufficient resources, it will remove products it deems most hazardous. [...]