Amphastar Sues FDA Over Seized Heparin, Delayed ANDA Approval

摘要

Amphastar is suing the FDA for detaining two shipments of raw heparin, saying the holdup is part of a pattern of arbitrary regulatory treatment and has delayed the approval of its generic version of the blood thinner Lovenox.rnThe FDA has not adequately justified its continued detention of the semipurified heparin, which is used in the manufacture of generic Lovenox (enoxa-parin sodium), according to the suit filed Oct. 25 in the U.S. District Court for the District of Columbia. Amphastar is asking the court to enjoin the FDA from continuing to detain the materials.