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6 June 2017Americas

Court grants order to resolve Amgen v FDA paediatric dispute

A district court has granted a stipulated order to the US Food and Drug Administration (FDA) and Amgen, after they jointly asked the court to end a case centring on paediatric exclusivity for Sensipar (cinacalcet).

Sensipar is a management treatment for patients with secondary hyperparathyroidism.

The motion was filed at and accepted by the US District Court for the District of Columbia yesterday. The court also stayed the case.

The parties said that they asked for the court action to be stopped in an effort to avoid the need for a temporary restraining order (TRO) and preliminary injunction.

Amgen sued the FDA in May to push the FDA to accept its study reports and give it six months of paediatric exclusivity for Sensipar.

According to the lawsuit filed by Amgen at the same district court, Congress requires the FDA to grant six months of additional market exclusivity and patent protection to drugs for which paediatric studies were conducted, in response to an FDA request for study reports.

This, Amgen added, is to encourage drug sponsors to develop critical information about the safety and efficacy of drugs.

The company claimed that the FDA is required to accept the study reports and grant exclusivity as long as the studies “fairly respond” to the FDA’s request.

Now the parties have said in their motion that they have engaged in “meaningful discussions”.

Amgen and the FDA said: “If the stipulated order is acceptable to and entered by the court, the parties believe that it would moot the pending TRO motion.”

The court agreed to the request and granted the stipulated order, and the FDA will accept resubmission of Amgen’s request for dispute resolution.

The FDA’s decision on the order will be made by June 26.

The court said that if Amgen’s study reports are deemed acceptable by the FDA, the agency will update the Orange Book to “reflect paediatric exclusivity in the first business day following acceptance”.

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Americas
1 August 2018   Generic drug maker Amneal has secured a finding of non-infringement in a Hatch-Waxman case over kidney disease drug Sensipar (cinacalcet hydrochloride).

More on this story

Americas
1 August 2018   Generic drug maker Amneal has secured a finding of non-infringement in a Hatch-Waxman case over kidney disease drug Sensipar (cinacalcet hydrochloride).