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2008 505(b)(2) Approvals

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%.