FDA Accepts Tercica's Increlex NDA With Priority Review

The FDA has accepted for filing and granted priority review of Tercica's new drug application (NDA) for Increlex, or recombinant human insulin-like growth factor-1 (rhIGF-1).

The company is seeking approval to market Increlex (mecasermin [rDNA origin] injection) for the long-term treatment of short stature caused by a severe form of primary IGF-1 deficiency (Primary IGFD).

Based on the priority-review designation, the FDA has six months from the submission date, by Aug. 31, to take action on the NDA filing.