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April 8-12, 2002, Generic Pharmaceutical Association Annual Meeting andEducational Conference - Presentationshttp://www.fda.gov/cder/ogd/index.htm#NewLabeling Updateshttp://www.fda.gov/cder/ogd/rld/labeling_review_branch.htmlNew and Generic Drug Approvals [includes Drug Label and Approval Letter]http://www.fda.gov/cder/approval/index.htmAccutane (isotretinoin) Capsules, Hoffmann-La Roche Inc.ADDERALL CII (Mixed Salts of a Single-Entity Amphetamine Product) Tablets,Shire Pharmaceutical Development Inc.Ceftin (cefuroxime axetil) Tablets and Oral Suspension, GlaxoKlineCerumex (triethanolamine polypeptide oleate-condensate otic solution), ThePurdue Frederick CompanyNovolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo NordiskPharmaceuticals, Inc. supp32Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo NordiskPharmaceuticals, Inc. supp 33NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk supp2NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk supp4Sporanox (itraconazole) Capsules, and PharmaceuticalResearch and Development. L.L.C.Trusopt (dorzolamide hydrochloride ophthalmic solution), Merck & Co., Inc.Vioxx (rofecoxib) Tablets & Suspension, Merck & Co. Inc.April 16, 2002Approved Active Moieties to which FDA has Issued a Written Request forPediatric Studies under Section 505A of the Federal Food, Drug, and CosmeticAct http://www.fda.gov/cder/pediatric/wrlist.htmDietary supplement company signs a consent decree prohibiting the companyfrom making or distributing unapproved new drugs, including productscontaining ephedrine hydrochloride or any synthetic ephedrine alkaloid. FDANews. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00802.htmlGeneric Drug Approvals for March 2002Approvals http://www.fda.gov/cder/ogd/approvals/AP0302.htmFirst-Time Generics http://www.fda.gov/cder/ogd/approvals/1st0302.htmTentative Approvals http://www.fda.gov/cder/ogd/approvals/TA0302.htmHuman Drug Advisory Committee Rosters (Updated)http://www.fda.gov/cder/audiences/acspage/acslist1.htmNew and Generic Drug Approvals [includes Drug Label and Approval Letter]http://www.fda.gov/cder/approval/index.htmAkineton (biperiden) Tablet, Abbott LaboratoriesAmaryl (glimepiride Tablets, Aventis PharmaceuticalsAmiodarone Hydrochloride Injection, Faulding Pharmaceutical Co., TentativelyApprovedCarnitor (levocarnitine) Tablets, Oral Solution & Injection, Sigma-TauPharmaceuticals, Inc.Clarinex (Deloratadine) Tablets, Schering CorporationEmbeline Gel, 0.05% (Clobetasol Propionate Gel, 0.05%, Healthpoint, Ltd.Hydroxyzine Hydrochloride Syrup USP, Vintage Pharmaceuticals, Inc.Miradon (anisindione) Tablets, Schering CorporationPotassium Chloride Extended-release Tablets USP, Andrx Pharmaceuticals, Inc.Prednisolone Syrup USP, KV Pharmaceutical CompanyTranxene (clorazepate dipotassium) dosages, Abbott LaboratoriesTrizivir (abacavir sulfate, lamivudine, zidovudine), GlaxoKlineValium (diazepam) Tablets & Injection, Roche Products Inc.Patent Term Extension and New Patents Docket Number *95S-0117http://www.fda.gov/cder/orange/docket.pdfPediatric Exclusivity Statistics as of February 1, 2002http://www.fda.gov/cder/pediatric/wrstats.htmPediatric Labeling Changes effected under Section 505A of the Federal Food,Drug, and Cosmetic Act as of February 15, 2002http://www.fda.gov/cder/pediatric/labelchange.htmApril 17, 2002New and Generic Drug Approvals [includes Drug Label and Approval Letter]http://www.fda.gov/cder/approval/index.htmAgenerase (amprenavir) Capsules and Oral Solution, GlaxoKlineBuSpar (Buspirone Hydrochloride) Tablets, Bristol-Myers Squibb Co.Cafcit (caffeine citrate) Injection & Oral Solution, O.P.R. Development,L.P.Ethamolin (ethanolamine oleate) Injection, Questcor Pharmaceuticals, Inc.Innohep (tinzaparin sodium) Injection, Bristol-Myers Squibb Pharma CompanyMinocin (minocycline hydrochloride) Oral Suspension, Wyeth-Ayerst ResearchMinocin (minocycline hydrochloride) Pellet-Filled Capsules, Wyeth-AyerstResearchMotrin Suspension, Chewable Tablets, Caplets & Oral Drops, McNeil ConsumerHealthcarePravachol (Pravastatin Sodium) Tablets, Bristol-Myers SquibbRocaltrol (calcitriol) Capsules & Oral Solution, Hoffmann-LaRoche Inc.VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, AgouronPharmaceuticals, Inc.Zoladex (goserelin acetate) Implant, AstraZeneca Pharmaceuticals LPZoladex (goserelin acetate) Implant, AstraZeneca Pharmaceuticals LPApril 18, 2002Comprehensive List of Guidance Documentshttp://www.fda.gov/cder/guidance/guidlist.pdfFDA approves new labeling information for Cytotec (misoprostol). CytotecLabel. (4/17/2002) http://www.fda.gov/cder/foi/label/2002/19268slr037.pdfFDA alerts healthcare professionals about new safety information on Mifeprex(mifepristone). Mifepristone Information. (4/17/2002)http://www.fda.gov/cder/drug/infopage/mifepristone/default.htmInternational Conference on Harmonization: Electronic Standards for theTransfer of Regulatory Information http://www.fda.gov/cder/m2/default.htmNew and Generic Drug Approvals [includes Drug Label and Approval Letter]http://www.fda.gov/cder/approval/index.htmAmoxicillin & Clavulanate Potassium Tablets USP, Geneva Pharmaceuticals,Inc., posted 4/18/02Celontin (methsuximide) Capsules, Parke- Pharmaceuticals Limited,posted 4/18/02Cipro (Ciprofloxacin Hydrochloride) Tablets & Cipro (ciprofloxacin) OralSuspension, Bayer Corporation, Pharmaceutical Division, posted 4/18/02Cipro (Ciprofloxacin) IV Solution, Bayer Corporation, PharmaceuticalDivision, posted 4/18/02Cutivate (fluticasone propionate) Cream, GlaxoKline, posted 4/18/02Estradiol Tablets USP, USL Pharma, Inc., posted 4/18/02Haldol (haloperidol) Tablets, Concentrate, Injection, and Haldol(haloperidol) Decanoate Injection, The R.W. Pharmaceutical ResearchInstitute, posted 4/18/02Metformin Hydrochloride Tablets, Andrx Pharmaceuticals, Inc., TentativelyApproved, posted 4/18/02Quixin (levofloxacin ophthalmic solution), Santen Incorporated, posted4/18/02Sinografin (diatrizoate meglumine and iodipimide meglumine injection),Bracco Diagnostics, posted 4/18/02April 19, 2002Division of Drug Marketing, Advertising, and Communicationshttp://www.fda.gov/cder/ddmac/index.htmDrug Interactions with Herbal Products & Food: Educational Symposium July22-23, 2002, The American Society for Clinical Pharmacology and Therapeutics(ASCPT), Bethesda, land. [Agenda and Registration ]http://www.ascpt.org/symposium411.pdfFDA issues Public Health Advisory: Contamination of Multi-dose Bottles ofAlbuterol Sulfate Solution for Inhalation (0.5%)http://www.fda.gov/cder/drug/advisory/albuterol.htmLabeling Updates (March 2002)http://www.fda.gov/cder/ogd/rld/labeling_review_branch.htmlNew Drug Approval ReportsCDER Response to Request for Fast Track Designationhttp://www.fda.gov/cder/rdmt/internetftstats.htmFast Track Designated Products Approved since 1998http://www.fda.gov/cder/rdmt/internetftap.htmNDA Approvals for Calendar Year 2000http://www.fda.gov/cder/rdmt/NDAAPS00CY.HTMNDA Approvals for Calendar Year 1999http://www.fda.gov/cder/rdmt/ndaaps99cy.htmTentative Advisory Committee Meetings, CDERhttp://www.fda.gov/cder/meeting/advisorycomyear.htm