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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 HydrochlorideTreandaCephalon20-Mar-08
Fospropofol DisodiumLusedraEisai Medical Research12-Dec-08
Iobenguane I 123 InjectionAdreViewGE Healthcare19-Sep-08
New Esters, Salts, or Other Noncovalent Derivatives
Bupropion HydrobromideAplenzinBiovail Labs23-Apr-08
Fenofibric AcidTrilipixAbbott15-Dec-08
Granisetron Transdermal SystemSancusoStrakan12-Sep-08
New Formulations
Abacavir Sulfate; LamivudineAbacavir SulfateAurobindo Pharma Ltd19-Dec-08
Amiodarone HydrochlorideNexteronePrism Pharma24-Dec-08
Cefepime InjectionCefepime InjectionBaxter05-Aug-08
EfavirenzEfavirenzAurobindo Pharma Ltd12-Dec-08
Fluorescein InjectionAk-FluorAkorn08-Aug-08
Lidocaine HydrochlorideAktenAkorn07-Oct-08
Phentolamine MesylateOraverseNovalar09-May-08
Prednisolone AcetateFlo-PredTaro17-Jan-08
Triamcinolone AcetonideTrivarisAllergan16-Jun-08
Valproic AcidStavzorBanner29-Jul-08
Venlafaxine HydrochlorideVenlafaxine HydrochlorideOsmotica20-May-08
Zolpidem TartrateZolpimistNovadel19-Dec-08
New Combinations
Adapalene; Benzoyl PeroxideEpiduoGalderma Labs08-Dec-08
Repaglinide/Metformin HydrochloridePrandiMetNovo Nordisk23-Jun-08
Sumatriptan; Naproxen SodiumTreximetPozen15-Apr-08
New Formulation and New Combination
Methyl Salicylate & MentholSalonpasHisamitsu20-Feb-08
Drug Already Marketed, but Without an Approved NDA
Morphine SulfateMorphine SulfateRoxane17-Mar-08 (2 NDAs)
Tentative Approvals
Docetaxel InjectionDocetaxel InjectionHospira Inc11-Aug-08
Pantoprazole SodiumPantoprazole SodiumTeva Parenteral20-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%.