Can 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 [...]
Archive for the 'Uncategorized' Category
AB Rated 505(b)(2)’s
Published September 11th, 2011 in 505(b)(2) Issues and Uncategorized. 0 CommentsKV’s Makena Part 4: Statistical versus Clinical Significance
Published June 14th, 2011 in Uncategorized. 0 CommentsIn previous postings (Intro, Part 1, Part 2, Part 3), I have provided background on KV’s Makena (17a-hydroxyprogesterone caproate injection aka 17P). The development and regulatory history contains many lessons. In this posting I’d like to examine the difference between statistical and clinical significance. Please note that this is not meant as a rigorous statistics [...]
We join everyone else this time of year and develop a list – ours is a list of FDA approvals made under 505(b)(2). As widely reported (WSJ article here) FDA reported that approvals were down in 2010. Frankly, it’s hard to tell what the figures are, let alone mean. The Agency sometimes includes approval of [...]
The media has been very involved in the Avandia case. Headlines or page 1 stories in the New York Times, Wall Street Journal and the British press seemed to take sides rather than report the facts (okay, I shouldn’t be surprised). Today, the day after the 2-day FDA Advisory Committee met to review the safety [...]
Advisory Committee Meeting: Rosiglitazone
Published July 12th, 2010 in Events, News Commentary and Uncategorized. 0 CommentsThe media is crazed with interpretations of the FDA and GSK briefing materials for the Advisory Committee meeting this week regarding the safety of Avandia (rosiglitazone). For those readers who’d like to read the original documents themselves, here are the links. July 13—14, 2010: Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee [...]
India Tightening Inspections on Raw Materials
Published June 25th, 2010 in Uncategorized. 0 CommentsCheaper is not always better. The cost of drug development demands that the pharmaceutical industry review the cost of all components of the program. In doing this, often the choice of the active pharmaceutical ingredient (API) manufacturer is driven by cost. Many of the API’s and raw materials are now coming from China. Any company [...]
In an overwhelming 19-1 vote , the FDA joint advisory committee meeting held yesterday (4/22/2010) recommended that the FDA not approve Acura/King’s proposed oxycodone + niacin tablet. As we commented on Wednesday of this week, the sponsor’s data showed that about 16% of the intended patients would experience flushing at a normal dose of oxycodone. Yet, [...]
Exalgo, hydromorphone extended release tablet was approved March 1, 2010. I waited a couple of days to see if it was approved under 505(b)(1) or 505(b)(2). At this writing, we don’t know. We have previously detailed in this blog the regulatory approval saga for this drug. When we last heard, FDA had told CombinatoRx/Covidien/Alza (clinical [...]
Do Not Neglect Your Third-Party Drug Substance Manufacturer
Published March 2nd, 2010 in Uncategorized. 0 CommentsAnother example of the importance CMC was reported in January. Warner Chilcott plc received a complete response letter from the FDA. The “low dose” oral contraceptive NDA was the file in question. The FDA inspection of the third-party drug substance manufacturing facility and control testing laboratory used to support the application reported outstanding deficiencies which [...]
2012 PDUFA User Fees
Published August 7th, 2011 in News Commentary and Uncategorized. 0 CommentsThe 2012 PDUFA User Fees have been announced in the Federal Register. In summary, the fees are: Applications: Full – requiring clinical data (e.g., Phase 2 or 3): $1,841,500 Not requiring clinical data : 920,750 Supplements requiring clinical data : 920,750 Establishment fee: $520,100 Product: $98,970 For those doing the math, the cost [...]