I am hesitant to contribute more information about so-called DESI drugs at the risk of further confusion. My goal is always to provide clarity, so here goes. Fundamental to any discussion about DESI products is the definition of a drug product. Let’s just focus on one part of the definition – the labeling. A drug [...]
Archive for the '505(b)(2) Issues' Category
Don’t launch unapproved products after 9/19/2011
Published October 3rd, 2011 in 505(b)(2) Issues. 0 CommentsI had a call from a client who wondered if he could launch a new ‘DESI’ product. He had just read the FDA’s recent announcement that it would take immediate enforcement action on any unapproved drug introduced into the market after September 19, 2011. So, the question he asked was, is his “DESI” drug an [...]
AB Rated 505(b)(2)’s
Published September 11th, 2011 in 505(b)(2) Issues and Uncategorized. 0 CommentsCan you have an “AB” rated 505(b)(2)? Yes, as well as other Therapeutic Equivalent (TE) codes that are most often associated with the TE codes for generics in the Orange Book. Several years ago when I was speaking about the potential products that qualified under 505(b)(2) I had a line in a PowerPoint slide for [...]
Contrave® Rejection: The Long and the (Too) Short of it
Published February 21st, 2011 in 505(b)(2) Issues and News Commentary. 0 CommentsOn February 1st Orexigen(R) Therapeutics, Inc. and Takeda Pharmaceutical Company Limited (Takeda) announced that the FDA issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss (http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID=1522207&highlight=). In the letter, FDA [...]
Injectables: 505j or 505(b)(2)?
Published February 1st, 2011 in 505(b)(2) Issues, ANDA's and Formulation Issues. 0 CommentsGeneric injectable drug products are treated differently than other routes of administration when it comes to permitted differences from the RLD. For most dosage forms, the sponsor is allowed to change excipients as long as the test product is bioequivalent to the RLD. No so for injectables, the excipients must be the same. If the [...]
REMS for 505(b)(2) products?
Published January 19th, 2011 in 505(b)(2) Issues, ANDA's and News Commentary. 0 CommentsCamargo has been involved in the development of several opioids and is often contacted by new sponsors to develop alternate formulations. One question often brought up is: does a 505(b)(2) approved opioid require a REMS (Risk Evaluation and Mitigation Strategies — for more information on REMS see a previous posting)? The short answer is: of [...]
PDUFA Fee Waiver: Plan Ahead
Published December 20th, 2010 in 505(b)(2) Issues and How to:. 0 CommentsFor an original NDA, whether it is a 505(b)(1) or 505(b)(2), there is a PDUFA fee to be paid at the time of the submission of the application or the FDA will refuse to file it. For a small business ( a company of less than 500 employees) the fee can be waived for its [...]
Endpoint for GI Toxicity Clarified
Published November 22nd, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsNSAIDs are known to induce gastrointestinal (GI) tract toxicity, notably upper GI tract. Drugs that suppress gastric acid secretion such as histamine type 2 receptor antagonists, proton pump inhibitors (PPIs), NSAIDs (e.g., COX-2 selective drugs), and misoprostol (a prostaglandin E analog that also has mucosal protective properties) have been studied for their ability to protect [...]
Most of us know that a BA/BE study of a generic can be done without an IND (the exception, called a Bio-IND, is when the drug being studied is cytotoxic or a radioactive labeled drug). In 505(b)(2) drug development we often are studying the BA/BE of a test drug versus an RLD as part of [...]
What is the Pediatric Drug Development Approach for Rare Diseases and Orphan Drugs?
Published March 23rd, 2011 in 505(b)(2) Issues and News Commentary. 0 CommentsAs part of the PDUFA V reauthorization discussions, the FDA and industry are talking about better approaches to rare disease drug development and orphan drugs. Public interests and Congress have mandated that FDA develop new guidances on the required studies needed for NDA approval. In these discussions, participants refer to the “pediatric drug development approach” [...]