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Chronological Index of : Regulatory

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  • Arixtra fondaparinux regulatory update

    GlaxoSmithKline plc (LSE:GSK; GSK), London, U.K. Product: Arixtra fondaparinux Business: Cardiovascular CHMP issued a positive opinion to expand the label of Arixtra fondaparinux 2.5 mg injection to include the …

    Published on 6/25/2007
  • Atriance nelarabine regulatory update

    GlaxoSmithKline plc (LSE:GSK; GSK), London, U.K. Product: Atriance nelarabine (Arranon-U.S.) Business: Cancer CHMP issued a positive opinion to grant marketing approval to an MAA for Atriance nelarabine from GSK to …

    Published on 6/25/2007
  • Ceftobiprole regulatory update

    Basilea Pharmaceutica AG (SWX:BSLN), Basel, Switzerland Johnson & Johnson (JNJ), New Brunswick, N.J. Product: Ceftobiprole (BAL5788) Business: Infectious JNJ's Janssen-Cilag unit submitted an MAA to EMEA for …

    Published on 6/25/2007
  • Celsentri maraviroc regulatory update

    Pfizer Inc. (PFE), New York, N.Y. Product: Celsentri maraviroc Business: Infectious PFE received an approvable letter from FDA for Celsentri maraviroc for use in combination with other antiretroviral agents for …

    Published on 6/25/2007
  • ChondroCelect regulatory update

    TiGenix N.V. (Euronext:TIG), Haasrode, Belgium Product: ChondroCelect Business: Musculoskeletal TIG submitted an MAA to EMEA for ChondroCelect to treat full thickness cartilage defects of the knee. The company hopes for…

    Published on 6/25/2007
  • Crixivan indinavir sulphate regulatory update

    Merck & Co. Inc. (MRK), Whitehouse Station, N.J. Product: Crixivan indinavir sulphate (MK-639, L-735524) Business: Infectious CHMP issued a recommendation to add a contraindication for the concomitant use of Crixivan …

    Published on 6/25/2007
  • Davanat regulatory update

    Pro-Pharmaceuticals Inc. (PRW), Newton, Mass. Product: Davanat Business: Cancer PRW began submission of an NDA under section 505(b)(2) of the Food, Drug and Cosmetic Act for Davanat in combination with intravenous …

    Published on 6/25/2007
  • Differin adapalene gel 0 regulatory update

    Galderma S.A., Lausanne, Switzerland Product: Differin adapalene gel 0.3% Business: Dermatology FDA approved an NDA for Differin adapalene topical gel 0.3% to treat moderate to moderately severe acne. The company …

    Published on 6/25/2007
  • Epoetin alfa regulatory update

    Medice Arzneimittel Ptter GmbH & Co.KG, Iserlohn, Germany Novartis AG (NVS; SWX:NOVN), Basel, Switzerland Product: Epoetin alfa Business: Hematology CHMP recommended the European Commission approve three applications …

    Published on 6/25/2007
  • Exforge regulatory update

    Novartis AG (NVS; SWX:NOVN), Basel, Switzerland Product: Exforge Business: Cardiovascular FDA granted final marketing approval for Exforge, a fixed-dose combination of the calcium channel blocker amlodipine and the …

    Published on 6/25/2007
  • Flebogammadif regulatory update

    Grifols S.A., Barcelona, Spain Product: Flebogammadif Business: Hematology CHMP issued a positive opinion for the approval of Flebogammadif human intravenous immunoglobulin (IVIg) for replacement therapy in …

    Published on 6/25/2007
  • Gliolan regulatory update

    Medac GmbH, Wedel, Germany Product: Gliolan Business: Diagnostic CHMP issued a positive opinion for the approval of Medac's gliolan 5-aminolevulinic acid hydrochloride as an imaging agent to visualize malignant tissue …

    Published on 6/25/2007
  • Intuniv guanfacine GXR regulatory update

    Shire plc (LSE:SHP; SHPGY), Basingstoke, U.K. Product: Intuniv guanfacine GXR Business: Neurology SHP received an approvable letter from FDA for Intuniv guanfacine (formerly Connexyn) extended-release tablets to treat …

    Published on 6/25/2007
  • IV Genasense oblimersen regulatory update

    Genta Inc. (GNTA), Berkeley Heights, N.J. Product: IV Genasense oblimersen Business: Cancer GNTA plans to submit a request to FDA's Center for Drug Evaluation and Research (CDER) within the next 4 weeks for a review of…

    Published on 6/25/2007
  • Ixabepilone regulatory update

    Bristol-Myers Squibb Co. (BMY), New York, N.Y. Product: Ixabepilone (BMS-247550) Business: Cancer FDA accepted for filing and granted Priority Review to an NDA for ixabepilone to treat patients with metastatic or …

    Published on 6/25/2007
  • Kaletra lopinavir/ritonavir regulatory update

    Abbott Laboratories (ABT), Abbott Park, Ill. Product: Kaletra lopinavir/ritonavir Business: Infectious CHMP recommended adding a contraindication for the concomitant use of Kaletra lopinavir/ritonavir with oral …

    Published on 6/25/2007
  • Lexiva fosamprenavir calcium regulatory update

    Vertex Pharmaceuticals Inc. (VRTX), Cambridge, Mass. GlaxoSmithKline plc (LSE:GSK; GSK), London, U.K. Product: Lexiva fosamprenavir calcium (Telzir - EU) Business: Infectious CHMP recommended adding a contraindication …

    Published on 6/25/2007
  • Lyrica pregabalin regulatory update

    Pfizer Inc. (PFE), New York, N.Y. Product: Lyrica pregabalin Business: Musculoskeletal FDA approved PFE's Lyrica pregabalin capsules for the treatment of fibromyalgia. The GABA receptor agonist is already approved in …

    Published on 6/25/2007
  • Nexavar sorafenib regulatory update

    Onyx Pharmaceuticals Inc. (ONXX), Emeryville, Calif. Bayer AG (FSE:BAY; BAY), Leverkusen, Germany Product: Nexavar sorafenib Business: Cancer BAY submitted an MAA to EMEA for Nexavar sorafenib to treat hepatocellular …

    Published on 6/25/2007
  • Norvir ritonavir regulatory update

    Abbott Laboratories (ABT), Abbott Park, Ill. Product: Norvir ritonavir Business: Infectious CHMP recommended adding a contraindication for the concomitant use of Norvir ritonavir with oral midazolam. The soft-gel …

    Published on 6/25/2007
  • Nuvigil armodafinil regulatory update

    Cephalon Inc. (CEPH), Frazer, Penn. Product: Nuvigil armodafinil Business: Neurology FDA approved CEPH's Nuvigil armodafinil to treat excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea …

    Published on 6/25/2007
  • NV-101 regulatory update

    Novalar Pharmaceuticals Inc., San Diego, Calif. Product: NV-101 Business: Neurology FDA accepted for filing an NDA for NV-101 to reverse locally applied dental anesthesia. Novalar said it expects the application, which …

    Published on 6/25/2007
  • Pafuramidine maleate regulatory update

    Immtech Pharmaceuticals Inc. (IMM), Vernon Hills, Ill. Product: Pafuramidine maleate (DB289) Business: Infectious FDA granted Orphan Drug designation for pafuramidine maleate to treat malaria. The binder of parasite DNA…

    Published on 6/25/2007
  • Prezista darunavir regulatory update

    Johnson & Johnson (JNJ), New Brunswick, N.J. Product: Prezista darunavir Business: Infectious CHMP recommended adding a contraindication for the concomitant use of JNJ's Prezista darunavir with oral midazolam. The …

    Published on 6/25/2007
  • RealTime HBV test regulatory update

    Celera Genomics Group (CRA), Rockville, Md. Abbott Laboratories (ABT), Abbott Park, Ill. Product: RealTime HBV test Business: Diagnostic ABT received CE Mark approval in Europe for its real-time PCR test to detect HBV …

    Published on 6/25/2007

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