Sandoz Tries An Authorized Generic Argument To Relaunch At-Risk Skelaxin
This article was originally published in The Pink Sheet Daily
Executive Summary
A temporary restraining order is blocking Sandoz's generic version of King's muscle relaxant, but CorePharma's launch of an authorized generic means the TRO should be lifted, Sandoz argues.
You may also be interested in...
Legal Briefs: Rx Data Mining Law Upheld, Angiomax Patent Extended, Accutane Verdict Vacated
First Circuit upholds Maine law on prescribers' privacy: A Maine statute allowing physicians to choose not to make identifying information about their prescribing available for use in marketing is constitutional, the U.S. Court of Appeals for the First Circuit ruled Aug. 4. IMS Health, Verispan and Source Healthcare Analytics filed suit to block the law claiming its restrictions on use of prescribers' identifying data limited free speech and also regulated transactions outside of Maine in violation of the dormant Commerce Clause. In 2008, the First Circuit upheld a similar New Hampshire law that banned the sale of physician prescribing data (1"The Pink Sheet," Nov. 24, 2008). In the current case, IMS v. Mills, the court said the statute regulates conduct not speech and that it "constitutionally reaches plaintiffs' out-of-state transactions as a necessary incident of Maine's strong interest in protecting opted-in Maine prescribers from unwanted solicitations.
Legal Briefs: Rx Data Mining Law Upheld, Angiomax Patent Extended, Accutane Verdict Vacated
First Circuit upholds Maine law on prescribers' privacy: A Maine statute allowing physicians to choose not to make identifying information about their prescribing available for use in marketing is constitutional, the U.S. Court of Appeals for the First Circuit ruled Aug. 4. IMS Health, Verispan and Source Healthcare Analytics filed suit to block the law claiming its restrictions on use of prescribers' identifying data limited free speech and also regulated transactions outside of Maine in violation of the dormant Commerce Clause. In 2008, the First Circuit upheld a similar New Hampshire law that banned the sale of physician prescribing data (1"The Pink Sheet," Nov. 24, 2008). In the current case, IMS v. Mills, the court said the statute regulates conduct not speech and that it "constitutionally reaches plaintiffs' out-of-state transactions as a necessary incident of Maine's strong interest in protecting opted-in Maine prescribers from unwanted solicitations.
King Assures Investors Embeda Marketing Materials Not Lost In DDMAC "Black Hole"
Five months after the launch of King's oral morphine Embeda, execs still await FDA approval of marketing materials.