Replies to post #33631 on Amarin Corp Plc (AMRN)

[oldberkeley]

Congrats DEPO.....FDA are scum!

OT: They make some mistakes as do all bureaucracies everywhere, but if you'd prefer for you and your family to live in a country where food and drug safety is effectively unmonitored, Somalia would be an excellent choice.

[sts66]

NEWARK, Calif., Sept. 5, 2014 /PRNewswire/ -- Depomed, Inc. (Nasdaq:DEPO) today announced that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted Depomed's motion for summary judgment in the company's lawsuit against the United States Food and Drug Administration seeking an order requiring the FDA to grant Gralise(®) (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN).

The court's ruling requires that the FDA grant Orphan Drug exclusivity for Gralise for the management of PHN.

Weird - how/why would one sue for orphan drug status? I can understand wanting exclusivity, but not sure how orphan drug if forced upon FDA? Also, isn't that the same judge that's in charge of our NCE or AZN case?