Recently we considered the case of a 505(b)(2) NDA without an RLD. So let’s ask if a 505(b)(2) NDA have more than one RLD? In a word, the answer is “yes”!
When using the 505(b)(2) regulatory pathway, Sponsors may rely on the Agency’s previous findings of safety and/or efficacy of an already approved product which is [...]
Archive for October, 2009
Reference Listed Drugs (RLDs)—Can more than one be used?
Published October 30th, 2009 in 505(b)(2) Issues. 0 CommentsOn 30 September 2009, the FDA issued a new draft guidance for industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. The guidance describes the content and format of a REMS, which the FDA was authorized to require by provisions of the FDA Amendments Act (FDAAA) [...]
505(b)(2) Submissions: No RLD
Published October 28th, 2009 in 505(b)(2) Issues and 505(b)(2) Process. 1 CommentTwo weeks ago (10/14/09) I had the pleasure to present at the Drug Repositioning Summit in Boston. I started my talk by asking the audience if a 505(b)(2) application required a Reference Listed Drug (RLD). Most replied affirmatively. My talk was on 505(b)(2)’s without an RLD.
Let’s take a look at the regulation itself:
Notice that there is no mention [...]
Did FDA make a mistake? Prodrug Emend exclusivity reconsidered
Published October 27th, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsIt is important to give the FDA credit for admitting mistakes. Yesterday’s posting in this blog concerned Vyvance’s NCE and 5 year exclusivity status.
The thorough response by the FDA to the Actavis request for reconsideration of the new chemical entity (NCE) 5 year exclusivity granted to Vyvanse (lisdexamfetamine dimesylate) Capsules, the prodrug of dexamphetamine, included [...]
FDA Reaffirms 5-year Exclusivity for a Pro-drug
Published October 26th, 2009 in 505(b)(2) Issues and News Commentary. 1 CommentFDA has reaffirmed its prior assignment of 5 years exclusivity to Vyvance (lisdexamfetamine dimesylate). When Vyvance was approved in 2007, this prodrug of dextramphetamine was given NCE status with a 5 year exclusivity. With this exclusivity, the FDA may not accept an ANDA before the exclusivity expires unless a paragraph IV is filed, in which [...]
On September 30, U.S. District Court (New Hampshire) judge Joseph Laplante decided that Mutual Pharmaceutical was obligated by New Hampshire law to include warnings on its ANDA products not included on the reference listed drug’s labeling. The judge ruled that, although the Hatch-Waxman amendment clearly stated that the the ANDA must contain the same wording as [...]
505(b)(2) for formulation changes
Published October 20th, 2009 in 505(b)(2) Issues and Formulation Issues. 0 CommentsA couple of weeks ago I was invited to present at the 2009 Nebraska Research and Innovation Conference. The theme of my talk was “The Case for Improving Existing Drugs”.
There are several factors driving people to the 505(b)(2) development pathway, a couple of which are:
Generic cliff. By about 2017 there will be very few remaining [...]
Is there a market for your drug?
Published October 19th, 2009 in How to: and Uncategorized. 0 CommentsAt Camargo, we can help clients evaluate the market potential of their proposed drug product by examining factors that might influence the resulting medical position at the time of product launch. When desired or needed for potential fund-raising, we can also perform a full marketing forecast. One aspect of this is to look at market [...]
Camargo is once again attending and exhibiting at the AAPS Annual Meeting and Exposition in Los Angeles November 8-12. We have complimentary passes to the exhibit floor. Please email your request to services@camargopharma.com and I will send one or more passes to you.
Intermezzo® Held Up at FDA
Published October 29th, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsTranscept Pharmaceuticals announced yesterday (10/28/09) that it had received a complete response letter from the FDA concerning its NDA for Intermezzo® (zolpidem tartrate sublingual tablet). We’ve been following this drug in this blog for a couple of years. Recall that this drug is for the treatment of insomnia when a person awakens in the middle [...]