Amphastar

Meanwhile, Amphastar's application was on hold, because one of its Chinese suppliers was linked to a contaminated heparin batch, leading to numerous FDA inspections of Amphastar facilities, according to the company.

New Generic Lovenox Receives FDA Approval Alicia Mundy 2011

Amphastar sued the FDA after the agency approved Momenta's application in July 2010, saying the FDA illegally quarantined Chinese heparin needed for its drug development.

New Generic Lovenox Receives FDA Approval Alicia Mundy 2011

It said the FDA allowed one shipment through Los Angeles International Airport from China in mid-May, but notified Amphastar unexpectedly that the permit was a mistake on July 22, the day before Momenta's application was approved.

Drug Maker Sues FDA on Denial of Heparin Imports Alicia Mundy 2010

The action by Amphastar Pharmaceuticals Inc. brings into federal court a bitter dispute over the FDA's handling of the battle to sell generic forms of Lovenox, a blood thinner that brought Sanofi-Aventis SA about $4 billion in 2009.

Drug Maker Sues FDA on Denial of Heparin Imports Alicia Mundy 2010

Amphastar said its shipment troubles "are part of a broader pattern of arbitrary, capricious and vindictive behavior" by the FDA that includes more than a dozen inspections "designed to harass Amphastar."

Drug Maker Sues FDA on Denial of Heparin Imports Alicia Mundy 2010

Amphastar filed its application to make generic Lovenox in 2003.

Drug Maker Sues FDA on Denial of Heparin Imports Alicia Mundy 2010

Amphastar said its FDA application can't be completed unless it gets the shipments.

Drug Maker Sues FDA on Denial of Heparin Imports Alicia Mundy 2010

In 2009, Amphastar, frustrated at the delay, alleged in a series of letters that the FDA had been showing bias towards Momenta, citing, among other things, contacts between Mo menta's top scientist and the FDA's chief drug regulator.

Drug Maker Sues FDA on Denial of Heparin Imports Alicia Mundy 2010

Amphastar said its imported heparin product presents "no threat whatsoever to the drug-consuming public" because that heparin is not intended for consumers.

Drug Maker Sues FDA on Denial of Heparin Imports Alicia Mundy 2010

Amphastar has accused the FDA of bias toward Momenta.

Drug Maker Sues FDA on Denial of Heparin Imports Alicia Mundy 2010