Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
196 In 2008, the Center for Drug Evaluation and Research in the US Food and Drug Administration approved 24 new drugs: 21 new molecular entities (NMEs) and 3 new biologics license applications (BLAs). A list of NME and BLA approvals from January 2008 through April 2009 is outlined below. New Molecular Entity and Biologics License Approvals (Jan. 2008–Apr. 2009)* Applicant (approval date) Proprietary name (active ingredient) Dosage form (route) Indication Adolor (May 20, 2008) Entereg (alvimopan) Capsule (oral) Restoration of bowel function following bowel resection surgery Amgen (Aug. 22, 2008) Nplate (romiplostim) Injectable (subcutaneous) Idiopathic thromboxytopenic purpura Bayer HealthCare (Jul. 3, 2008) Eovist Solution (gadoxetate disodium) (intravenous) Magnetic resonance imaging of the liver Centocor Ortho Biotech (Apr. 24, 2009) Simponi (golimumab) Injectable (injection) Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis Cephalon (Mar. 20, 2008) Treanda (bendamustine hydrochloride) Powder (intravenous) Chronic lymphocytic leukemia CV Therapeutics (Apr. 10, 2008) Lexiscan (regadenoson) Solution (intravenous) Pharmacologic stress agent for radionuclide myocardial perfusion imaging Cypress Bioscience (Jan. 14, 2009) Savella (milnacipran hydrochloride) Tablet (oral) Fibromyalgia Eisai Medical Research (Nov. 14, 2008) Banzel (rufinamide) Tablet (oral) Seizures from Lennox– Gastaut syndrome Eisai Medical Research (Dec. 12, 2008) Lusedra (fospropofol disodium) Solution (intravenous) Sedation in adults undergoing therapeutic or diagnostic procedures Epix Pharmaceuticals (Dec. 22, 2008) Vasovist (gadofosveset trisodium) Solution (intravenous) Magnetic resonance angiography Ferring Pharmaceuticals (Dec. 24, 2008) Degarelix acetate (degarelix acetate) Powder (subcutaneous) Prostate cancer GE Healthcare (Sept. 19, 2008) AdreView (lobenguane sulfate 123I) Solution (intravenous) Detection of primary and metastatic pheochromocytomas Genzyme (Dec. 15, 2008) Mozobil (plerixafor) Solution (subcutaneous) Stem-cell mobilization GlaxoSmithKline (Nov. 20, 2008) Promacta (eltrombopag olamine) Tablet (oral) Short-term idopathic thrombocytopenic pupura Ispen (Apr. 30, 2009) Dysport (abobutulinumtoxinA) Injectable (injection) Cervical dystonia and improvement of glabellar lines Medicines Company (Aug. 1, 2008) Cleviprex (clevidipine butyrate) Emulsion (intravenous) Blood-pressure reduction when oral therapy is not feasible Novartis (Mar. 30, 2009) Afinitor (everolimus) Tablet (oral) Advanced renal cell carcinoma Novartis Apr. 7, 2009 Coartem artemether/ lumefantrine) Tablet/oral Malaria infections Pharmaceutical Technology BUYERS GUIDE 2009 P h a r mTe c h . c o m medioimages/photodisc/getty images New Molecular Entities (Jan. 2008–Apr. 2009) Approved nmes INDUSTRY ALMANAC INDUSTRY ALMANAC New Molecular Entity and Biologics License Approvals (Jan. 2008–Apr. 2009)* Proprietary name (active ingredient) Dosage form (route) Indication Ortho-McNeilJanssen Pharmaceuticals (Nov. 20, 2008) Tapentadol hydrochloride (Tapentadol hydrochloride) Tablet (oral) Moderate to severe acute pain Pfizer (Oct. 31, 2008) Toviaz Tablet, extended (fesoterodine fumarate) release (oral) Overactive bladder Prestwick Pharmaceuticals (Aug. 15, 2008) Xenazine (tetrabenazine) Tablet (oral) Chorea of Huntington’s disease Progenics Pharmaceuticals (Apr. 24, 2008) Relistor (methylnaltrexone bromide) Solution (subcutaneous) Opiod-induced constipation Regeneron Pharmaceuticals (Feb. 27, 2008) Arcalyst (rilonacept) Vial (single-use) Cryopyrin-associated periodic syndromes Schwarz Biosciences (Oct. 28, 2008) Vimpat (lacosamide) Tablet (oral) and Solution (intravenous) Adjunctive therapy for partial onset of epileptic seizures Sciele Pharma (Apr. 9, 2009) Benzyl alcohol (Benzyl alcohol) Lotion (topical) Head lice Sirion Therapeutics (Jun. 23, 2008) Durezol (difluprednate) emulsion (ophthalmic) Inflammation and pain associated with ocular surgery Takeda Pharmaceutical (Feb. 13, 2009) Uloric (febuxostat) Tablet (oral) Chronic management of hyperuricemia Tibotec Pharmaceuticals (Jan. 18, 2008) Intelence (etravirine) Tablet (oral) HIV-1 infection UCB (Apr. 22, 2008) Cimzia (certolizumab pegol) Injectable (injection) Crohn’s disease Watson Pharmaceuticals (Oct. 8, 2008) Rapaflo (silodosin) Capsule (oral) Benign prosthetic hyperplasia Wyeth (Feb. 29, 2008) Pristiq (desvenlafaxine succinate) Tablet, extended release (oral) Major depressive order Approved nmes Applicant (approval date) * New molecular entities and new biologics license applications approved by the Center for Drug Research and Evaluation, US Food and Drug Administration. Adolor launched Entereg in collaboration with GlaxoSmithKline. Centocor Ortho Biotech is a subsidiary of Johnson & Johnson. Cephalon holds exclusive rights to market and develop Treanda in the US. CV Therapeutics was acquired by Gilead Sciences in April 2009 and operates as a subsidiary of Gilead Sciences. CV Theraeputics licensed North American rights of Lexiscan to Astellas Pharma US. Cypress Bioscience licenses the North American rights to Savella from Pierre Fabre, who originally developed and sells milnacipran outside the US. Savella is marketed by Forest Laboratories and Cypress Bioscience. Eisai Medical Research is the clinical development group of Eisai Corporation, a subsidiary of Eisai Co., Ltd (Tokyo). Epix Pharmaceuticals sold the US, Canadian, and Australian rights of Vasovist to Lantheus Medical Imaging in April 2009. Epix retains European and non-US rights (other than Canada and Australia). A collaboration for Vasovist between Epix and Bayer Schering Pharma ended Feb. 28, 2009. Ortho-McNeil-Janssen Pharmaceuticals is a subsidiary of Johnson & Johnson. Prestwick Pharmaceuticals was acquired by Biovail in 2008. Prestwick had an supply-and marketing agreement in the US for Xenazine with Ovation Pharmaceuticals prior to the acquisition. Ovation Pharmaceuticals was acquired by Lundbeck A/S in March 2009. Progenics jointly developed and commercialized Relistor with Wyeth. Schwarz Biosciences was the US subsidiary of Schwarz Pharma, which was acquired by UCB in 2007. Sciele Pharma was acquired by Shionogi & Co., Ltd in October 2009. Tibotec is a subsidiary of Johnson & Johnson. Source: Center for Drug Research and Evaluation of the US Food and Drug Administration and company information, accessed May 14, 2009. Pharmaceutical Technology BUYERS GUIDE 2009 197