For the first time, FDA’s new drug division has approved more 505(b)(2) drugs than those submitted via 505(b)(1). In 2006 and 2007, the percentage of 505(b)(2) drug approvals went from 20 to 43%, respectively.  The FDA publishes a list of drugs approved each year and this list for approvals through November, 2008 has a column “505(b)(2) Flag”.  We have found this column to be unreliable – several rows of (b)(1)’s are checked with a (b)(2) flag.  The following table was compiled by reviewing the approval documents for all new drugs approved in calendar 2008; these documents can be found by following the hyperlink for each drug product.

Established NameProprietary NameApplicantApproval

New Molecular Entities
Bendamustine Hydrochloride	Treanda	Cephalon	20-Mar-08
Fospropofol Disodium	Lusedra	Eisai Medical Research	12-Dec-08
Iobenguane I 123 Injection	AdreView	GE Healthcare	19-Sep-08
New Esters, Salts, or Other Noncovalent Derivatives
Bupropion Hydrobromide	Aplenzin	Biovail Labs	23-Apr-08
Fenofibric Acid	Trilipix	Abbott	15-Dec-08
Granisetron Transdermal System	Sancuso	Strakan	12-Sep-08
New Formulations
Abacavir Sulfate; Lamivudine	Abacavir Sulfate	Aurobindo Pharma Ltd	19-Dec-08
Amiodarone Hydrochloride	Nexterone	Prism Pharma	24-Dec-08
Amoxicillin	Moxatag	Middlebrook	23-Jan-08
Cefepime Injection	Cefepime Injection	Baxter	05-Aug-08
Efavirenz	Efavirenz	Aurobindo Pharma Ltd	12-Dec-08
Fluorescein Injection	Ak-Fluor	Akorn	08-Aug-08
Lidocaine Hydrochloride	Akten	Akorn	07-Oct-08
Mesalamine	Apriso	Salix	31-Oct-08
Phentolamine Mesylate	Oraverse	Novalar	09-May-08
Prednisolone Acetate	Flo-Pred	Taro	17-Jan-08
Triamcinolone Acetonide	Trivaris	Allergan	16-Jun-08
Valproic Acid	Stavzor	Banner	29-Jul-08
Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Osmotica	20-May-08
Zolpidem Tartrate	Zolpimist	Novadel	19-Dec-08
New Combinations
Adapalene; Benzoyl Peroxide	Epiduo	Galderma Labs	08-Dec-08
Niacin/Simvastatin	Simcor	Abbott	15-Feb-08
Repaglinide/Metformin Hydrochloride	PrandiMet	Novo Nordisk	23-Jun-08
Sumatriptan; Naproxen Sodium	Treximet	Pozen	15-Apr-08
New Formulation and New Combination
Methyl Salicylate & Menthol	Salonpas	Hisamitsu	20-Feb-08
Drug Already Marketed, but Without an Approved NDA
Morphine Sulfate	Morphine Sulfate	Roxane	17-Mar-08 (2 NDAs)
Tentative Approvals
Docetaxel Injection	Docetaxel Injection	Hospira Inc	11-Aug-08
Pantoprazole Sodium	Pantoprazole Sodium	Teva Parenteral	20-Oct-08

Based on the number of NDA’s that Camargo is compiling for just our clients, we expect 505(b)(2) to dominate the approval list in 2009.  Looking at the number of IND’s we are filing, we expect that by 2012, the percentage of 505(b)(2) approvals will be greater than 90%.