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CDER New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2008
Updated through July 31, 2008

NME New Drug Application (NDA) Approvals:

NDA Number Proprietary Name Established Name Applicant Review Classification Approval Date Indication
N022187 Intelence etravirine Tibotec P 18-Jan-08 Provides in combination with other antiretroviral agents for the the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
N021992 Pristiq desvenlafaxine succinate Wyeth S 29-Feb-08 Provides treatment of major depressive disorder.
N022249 Treanda bendamustine hydrochloride Cephalon P,O 20-Mar-08 Provides for the treatment of patients with chronic lymphocytic leukemia (CLL).
N022161 Lexiscan regadenoson CV Therapeutics S 10-Apr-08 Provides for the use as a pharmacologic stress agent for radionuclide myocardial perfusion imaging 0.4 mg/5 mL (0.08mg/mL).
N021964 Relistor methylnaltrexone bromide Progenics S 24-Apr-08 Provides for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
N021775 Entereg alvimopan Adolor S 20-May-08 Provides treatment of for the acceleration of time to gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
N022212 Durezol difluprednate Sirion P 23-Jun-08 Provides treatment of inflammation and pain associated with ocular surgery.
N022090 Eovist gadoxetate disodium Bayer S 03-Jul-08 Provides treatment for use in magnetic resonance imaging (MRI) of the liver in adult patients to provide contrast in the T1 weighted images to aid in the detection and characterization of focal liver pathologies in pre-surgical evaluation


New Biologic License Application (BLA) Approvals: 

BLA Number Proprietary Name Proper Name Applicant Review Classification Approval Date Indication
125249 Arcalyst rilonacept Regeneron P,O 27-Feb-08 Provides treatment for cryopyrin-associated periodic syndromes (CAPS).
125160 Cimzia certolizumab pegol UCB S 22-Apr-08 Provides for the treatment of reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have an inadequate response to conventional therapy.

Therapeutic Potentials:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - The drug appears to have therapeutic qualities similar to those of one or more already marketed drugs.
O -  Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

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Last Updated:August 15, 2008

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