On 11/3/2007 FDA issued a new MAPP* entitled “Acceptability of Standards from Alternative Compendia (BP/EP/JP)”. Although directed at new drugs, one can probably argue that the policy should also apply to the Office of Generic Drugs. Up to now, reviewers seemed arbitrarily accepting or denying the use of BP, EP and JP grade excipients and [...]
Archive for November, 2007
New MAPP for FDA Accepting Alternate Compendia for CMC standards
Published November 19th, 2007 in 505(b)(2) Issues and ANDA's. 0 Comments Cogentus Pharmaceuticals is working on a combination tablet that combines clopidogrel, the active ingredient in Plavix, with omeprazole, the API in Prilosec. Cogentus’s business strategy is to:
“… improv[e] the therapeutic profiles of existing, proven drugs in ways that take full advantage of their strengths while overcoming their well understood limitations. By combining complementary characteristics of two [...]
505(b)(2) - Part 2: The Assessment: Preclinical Review/Preclinical Plan
Published November 12th, 2007 in 505(b)(2) Process. 0 CommentsRats, mice, dogs, pigs - ANDA folks don’t have to deal with testing generic products in animals. As long as the excipients are previously approved, generic drugs don’t have to conduct any preclinical studies. 505(b)(2) development programs may need to include some preclinical studies depending mainly on whether the route of administration changes or FDA [...]
505(b)(2) - Part 2: The Assessment: Safety Review
Published November 8th, 2007 in 505(b)(2) Process. 0 CommentsOf course my product is safe! - the RLD was shown to be safe.
Perhaps so. The FDA approves products based on a risk/benefit; is the risk of taking the drug outweighed by the benefit? Would FDA approve the RLD using today’s standards? What changes from the RLD are we proposing to make in this development program [...]
505(b)(2) - Part 2: The Assessment: Efficacy Review
Published November 6th, 2007 in 505(b)(2) Process. 0 CommentsOne of the key attractions to the 505(b)(2) route is the potential of gaining approval with only one Phase 3 study. Moreover, this Phase 3 study is often small, at least compared to the thousands of patients in 505(b)(1) submissions. There are exceptions, to be sure. For example, 2 or more trials may be needed [...]
The US General Accounting Office (GAO) criticised what it concluded is a lack of FDA inspection of foreign API and finished dosage form manufacturers. This has received a lot of coverage in the lay and professional press, especially since a huge increase in API’s is coming from China; FDA has only 13 inspections scheduled in China, a country [...]
505(b)(2) - Part 2: The Assessment: Competitive Product(s) Review
Published November 5th, 2007 in 505(b)(2) Process. 0 CommentsWe investigate major factors that influence the potential clinical evidence required and the likelihood of a product’s acceptance in the market. Having established a working draft of our labeled indication(s), we look at the therapeutic category. What drugs have been used, are currently used and what drugs are being studied for eventual marketing?
This comparative review serves [...]
505(b)(2) - Part 2: The Assessment: Overview
Published November 1st, 2007 in 505(b)(2) Process. 0 CommentsWould you pack your suitcase for Hawaii if the plane is going to the Antarctica?
A drug product assessment. I cannot emphasize how important the first step is. Clients think they already know they have a good idea (they might!). Investors think they already have done their due diligence (probably not enough!). So why do only about 20% [...]
P&G Drops out of a 505(b)(2) Development
Published November 8th, 2007 in News Commentary. 0 CommentsNastech announced on 11/7/2007 that P&G had dropped out of their co-development of a nasally delivered version of Lilly’s osteoporosis drug Forteo (teriparatide). As reported, the Nastech CEO speculated that the reason for P&G’s termination of its participation was that original timescales for product development have had to be extended, meaning that the product may [...]