What a year for 505(b)(2) drug development! In 2011 FDA approved 44 505(b)(2) NDA submissions. Various authors have reported that FDA approved 34 or 35 drugs in 2011 (505(b)(1) NDA + BLA). I had speculated a couple of years ago that perhaps 80% of new drugs approved in 2012 would be 505(b)(2)’s, based on botha [...]
Archive for the 'Events' Category
2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals
Published January 9th, 2012 in 505(b)(2) Process and Events. 0 CommentsKV’s Makena®: A trove of 505(b)(2) Lessons
Published May 16th, 2011 in 505(b)(2) Process, Events and How to:. 0 CommentsOn February 3, 2011 Hologic, Inc. (subsequently sold assets to KV Pharmaceuticals) received 505(b)(2) approval of Makena®, its 17α-hydroxyprogesterone caproate injection (17P) to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The subsequent announcement that the price would be set at $1500 [...]
Will We Have Generic User Fees? Public Meeting To Be Held.
Published August 23rd, 2010 in ANDA's and Events. 0 CommentsOn the new drug side we have had user fees since 1992. The Prescription Drug User Fee Act (PDUFA) has been renewed many times. The Act provides that FDA will adhere to certain goals in return for fees levied on industry. The pharmaceutical industry has benefited from PDUFA in greater certainty of the timeframe for [...]
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 [...]
Orexigen® Therapeutics is developing a new fixed dose sustained-release (SR) combination of naltrexone and bupropion for the treatment of obesity. The rationale behind the two active ingredients is stated to be: Bupropion acts on the weight control circuit by stimulating the POMC neuron. Naltrexone prevents inhibition of POMC neurons by blocking the action of β-endorphin [...]
FDA Advisory Committee to Review Acura’s Oxycodone plus Niacin; Risk/Benefit in Question
Published April 21st, 2010 in 505(b)(2) Issues, Events and News Commentary. 2 CommentsAn FDA advisory meeting is scheduled tomorrow (4/22/2010) to review Acura Pharmaceuticals proposed Acurox® (oxycodone + niacin) immediate release tablets. Acura had submitted and NDA in December 2008 and received a Complete Response letter from FDA in June 2009 (a Complete Response letter is a denial of the approval but allowing for additional information). In [...]
505(b)(2): Repositioning, Repurposing or what?
Published April 20th, 2010 in 505(b)(2) Issues and Events. 0 CommentsLast week I made a presentation at the Society of Biomolecular Sciences (SBS) 2010 Annual Meeting in Phoenix (due to the Iceland volcano eruption, many participants are still there). The occasion was the inaugural meeting of the newly formed Special Interest Group for Repositioning Drugs (see the announcement of this new SIG). Dr. Chris Lipinsky [...]
I attended the Annual GPhA meeting this past week. This event is attended by the CEO’s and other top brass of most of the major generic pharmaceutical companies. This year was highlighted by a presentation from the FDA Commissioner, Dr. Margaret Hamburg. In her remarks, Dr. Hamburg admitted to a need for FDA to step up [...]
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 [...]
Approvals of ANDAs slows
Published February 21st, 2011 in ANDA's, Events and News Commentary. 0 CommentsI attended the 2011 Generic Pharmaceutical Association (GPhA) meeting last week. There was lots of useful information from several speakers. One area in particular stood out to me — the approvals of ANDAs are slowing and there is a growing awareness that the root cause is not just the Office of Generic Drugs (OGD). As [...]