Recent FDA action (through January 2010) related to testosterone undecanoate injection, telavancin, Ampligen, doxepin, everolimus, aztreonam lysine, erlotinib, TG4010, BSI-201, midazolam, Aimspro, Motorgraft, BHR-100, dextran sulfate
• Extended-duration testosterone undecanoate injection (Aveed, Endo Pharmaceuticals Holdings) for men diagnosed with low testosterone.
• Telavancin (Vibativ, Theravance) for the treatment of nosocomial pneumonia.
• Doxepin (Silenor, Somaxon Pharmaceuticals) for the treatment of insomnia.
Recommended for approval
• Everolimus (Novartis) for the prophylaxis of acute organ rejection in de novo kidney transplant recipients.
• Inhalable aztreonam lysine (Cayston, Gilead) for the treatment of lung infection caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
Not recommended for approval
• Erlotinib (Tarceva, OSI Pharmaceuticals and Roche's Genentech unit) for the treatment of advanced lung cancer.
Fast track designation
• TG4010 (Transgene) for the first-line treatment of advanced non-small cell lung cancer in combination with chemotherapy.
• BSI-201 (Sanofi-aventis, BiPar Sciences unit) combined with chemotherapy for the treament of breast cancer in patients with metastatic triple-negative breast cancer.
Orphan drug designation
• Midazolam (Ikano Therapeutics) for the acute treatment of certain forms of epileptic seizure known as cluster seizures or alternatively, as acute repetitive seizures.
• Anti-inflammatory agent (Aimspro, Daval International) for the treatment of amyotrophic lateral sclerosis.
• Stem cell-derived motor neuron product (Motorgraft, California Stem Cell) for the treatment of spinal muscular atrophy.
• BHR-100 (Progesterone, BHR Pharma) for treatment of traumatic brain injury.
• Low molecular weight dextran sulfate (IBsolvMIR, TikoMed) for preventing the rejection of transplanted pancreatic islet cells in type 1 patients.