completed Phase III trials with positive results 8/08 and 11/08; targeted market approval by 4Q/2009; NDA submitted 6/09 and accepted 8/09; FDA advisory board meeting scheduled for 2/24/2010, but will be rescheduled due to an administrative delay at FDA; PDUFA date 3/29/10; Advisory board rescheduled for 5/27/10 with PDUFA date changed to 7/27/10; FDA advisory board recommends drug 5/10; FDA review moved to 4Q10
Brand Egrifta Generic tesamorelin (TH9507)
Company name Theratechnologies, EMD Sorono Product type Speciality
Therapeutic category Endocrine and Diabetes Key uses HIV-associated lipodystrophy
Other Uses N/A Drug Class analogue of growth hormone releasing factor
Dosage From SC Expected Approval 2010-Q4
FDA Filing 6/09 Last Update date July 26,2010
Link to pipeline report
Link to news article
Link to clinicaltrials.gov
Link to press releases