BioCentury
ARTICLE | Clinical News

Solorel macimorelin regulatory update

October 1, 2012 7:00 AM UTC

Aeterna Zentaris said FDA did not grant Fast Track designation for AEZS-130 to diagnose adult growth hormone deficiency. Aeterna declined to disclose details. The company said it still plans to submit an NDA for the oral ghrelin-mimetic growth hormone secretagogue early next year. The compound has Orphan Drug designation from FDA for the indication. ...