Download APPROVED NMEs

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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.
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