As we have noted in this blog on several occasions, under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all new drug applications for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration are required to contain an assessment of the safety and effectiveness of the product [...]
Archive for the '505(b)(2) Issues' Category
Pediatric Assessments in Drug Development: timing in Europe vs. US
Published February 5th, 2010 in 505(b)(2) Issues, How to: and Uncategorized. 0 CommentsOnce Daily Trazodone Approved
Published February 4th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsYesterday, 2/3/10, FDA approved under 505(b)(2) Canadian-based Labopharm’s once-daily version of trazodone HCl for the treatment of depression (as of this writing, this approval is not posted on the FDA web site). The initial PDUFA date was July 18, 2009 but this was missed because FDA found issues when inspecting the API manufacturing facility – [...]
Getting Unapproved Drugs (DESI, etc.) Approved
Published December 22nd, 2009 in 505(b)(2) Issues. 0 CommentsFDA uses the term ‘Unapproved Drugs’ to refer to any drug that is marketed in the U.S. without FDA approval. There are hundreds, maybe thousands of these drugs in the U.S.. We have written about the efforts of FDA to remove them from the market. But also FDA has devoted a lot of resources to [...]
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 [...]
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 [...]
Reference Listed Drugs (RLDs)—Can more than one be used?
Published October 30th, 2009 in 505(b)(2) Issues. 0 CommentsRecently 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 [...]
On 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) [...]
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 [...]
Roche’s Actemra Approved For RA After Year’s Delay
Published February 11th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsJohn Jenkins, Office of New Drugs Director, remarked on the low rate (30 percent) of firstcycle approvals for standard review applications (‘The Pink Sheet,’ Dec. 7, 2008). He attributed the low approval rate in part to the submission of applications that require amendments, often because the original submissions were incomplete or incorrect. A recent example [...]