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:
||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.
||Provides treatment of major depressive disorder.
||Provides for the treatment of patients with chronic lymphocytic leukemia (CLL).
||Provides for the use as a pharmacologic stress agent for radionuclide myocardial perfusion imaging 0.4 mg/5 mL (0.08mg/mL).
||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.
||Provides treatment of for the acceleration of time to gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
||Provides treatment of inflammation and pain associated with ocular surgery.
||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:
||Provides treatment for cryopyrin-associated periodic syndromes (CAPS).
||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.
- 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
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