The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa—understandably has been big news, analyzed here and elsewhere.
Some are asking whether the FDA will pursue appellate review of the decision. An indication about that may come soon, as the District Court issued an order yesterday that directs the parties to meet and confer, and then file a joint letter by August 28, 2015 advising about “the future course of and next steps in the case.”
In the meantime, the District Court’s Opinion and Order is now available on Westlaw and Lexis as well: Amarin Pharma, Inc. v. FDA, No. 15 Civ. 35888, 2015 WL 4720039, 2015 U.S. Dist. LEXIS 103944 (SDNY Aug. 7, 2015).
Update: Per the attached document, the parties are discussing settlement and asked the court to stay the matter until October 30, 2015.
Further Update: The parties have requested a further stay, through December 17, 2015.