At first, Monday’s (11/16/09) news from CombinatoRx said that the FDA had told the company “that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo™ under Section 505(b)(1)”. Then, on Friday (11/20/09), the company said that the FDA had extended the PDUFA review date by 3 [...]
Archive for November, 2009
Qutenza: Approval of a “DESI-inspired” drug
Published November 20th, 2009 in Events and News Commentary. 0 CommentsThis week, NeurogesX, Inc. announced the FDA 505(b)(2) approval of Qutenza(TM), its 8% capsaicin patch, for management of post-herpetic neuralgia (PHN) - the nerve pain that can follow an attack of shingles. While not strictly speaking a DESI product, Qutenza can be considered “DESI-inspired,” because it is a first Rx approval for an active ingredient [...]
FDA approves Xanodyne’s tranexamic acid
Published November 16th, 2009 in Events and News Commentary. 0 CommentsXanodyne obtained 505(b)(2) approval for tranexamic acid for use in treating heavy menstrual bleeding (menorrhagia). The RLD is Cyklokapron(R) which is used to treat hemophilia and to reduce the need for replacement therapy during and following tooth extraction. The RLD received orphan approval in 1986. Initially, both tablet and injectable dosage forms were approved but [...]
Does Europe have a pathway for approval of drugs analogous to the FDA’s 505(b)2 pathway?
Published November 4th, 2009 in 505(b)(2) Process and How to:. 0 CommentsAs readers of this blog will know, a 505(b)(2) application is a US NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Under the right circumstances, either a new chemical entity [...]
GTx Needs a 2nd Phase III Trial and more safety data
Published November 4th, 2009 in News Commentary. 0 CommentsGTx announced 11/2/2009 that it has received a Complete Response Letter from the FDA concerning its NDA for TOREMIFENE CITRATE 80 mg (ACAPODENE®). The NDA, filed in late December 2008, sought approval for use of toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT). The NDA was based on [...]
A New Paradigm for the Development of Drugs for Type 2 Diabetes
Published November 4th, 2009 in 505(b)(2) Issues and How to:. 0 CommentsDue to Camargo’s on-going client projects in this area, our chief medical officer, Dr. Sam Kaba recently attended a DIA-sponsored conference in Washington, D.C. entitled Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science. His report:
The FDA Guidance for Industry on Evaluating Cardiovascular [...]
FDA Refuse to File: Merck Zetia & Pfizer Lipitor
Published November 3rd, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsMerck disclosed that FDA refused to file its 505(b)(2) NDA for the combination of Pfizer’s Lipitor (atorvastatin) with Zetia (ezetimibe). According to Merck’s disclosure, the FDA reason for he refusal is:
The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA’s response in order to determine a [...]
FDA warns P&G over use of Drug + Vitamin C
Published November 2nd, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsLast Thursday, 10/29/2009, FDA sent P&G a warning letter regarding Vicks DayQuil Plus Vitamin C and Vicks NyQuil Plus Vitamin C. The FDA takes the position that these two products are unapproved drugs because they combine a (OTC) drug and a dietary supplement. The relevant passage from the FDA warning letter is:
Notwithstanding your attempt to market each [...]
505(b)(2) - Giving Thanks
Published November 25th, 2009 in News Commentary. 0 CommentsNo turkey, no Black Friday specials, just a thank you note.
Little did we know that in 1984 Congress would provide for a regulatory pathway that would provide such a cornucopia of beneficial products that we see under development today. US consumers should give thanks for the role drugs play in improving health and extending lives, a [...]