FDA Pipeline preview, January 2010 (Testosterone undecanoate injection, Telavancin, Ampligen, Doxepin, Everolimus, Aztreonam lysine, Erlotinib, TG4010, BSI-201, Midazolam, Aimspro, Motorgraft, BHR-100, Dextran sulfate)

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

Complete response

• 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.