Xyrem definition

Xyrem means sodium oxybate oral solution, as sold by the Company under the brand name Xyrem®.
Xyrem means the sodium oxybate pharmaceutical product currently marketed under the trademark Xyrem and the sodium oxybate pharmaceutical product under development for treatment of fibromyalgia.

Examples of Xyrem in a sentence

  • Petitioner, in reliance on Mr. Valuck’s testimony, argues that a POSA would have been able to locate Exhibits 1003–1006 by exercising reasonable diligence, including being able to locate the Federal Register Notice for the Xyrem Advisory Committee Meeting and following the links.

  • FDA reviewers also prepared briefing information, including the Preliminary Clinical Safety Review of the Xyrem New Drug Application (“Safety Review”).

  • Exhibit 1004 is a Xyrem Preliminary Clinical Safety Review, asserted by Petitioner to have small portions redacted, thereby indicating an intent to make the document publicly available.

  • The May 14, 2001 Federal Register Notice provided public notice of the June 6, 2001 Xyrem Advisory Committee Meeting and identified the Universal Resource Locator (“URL” or website address) for the FDA website on which “[b]ackground material from the sponsor and FDA will be posted 24 hours before the meeting.” Pet.

  • The Federal Register Notice for the Xyrem Advisory Committee Meeting stated that a “main focus of the deliberations will be on risk management issues” related to Xyrem, a subject of direct interest to a POSA as defined above.

  • We provide a summary timeline below.May 3, 2001: FDA Safety Review of Xyrem completed (Ex. 1004, 1)May 3, 2001: Sponsor’s Xyrem Briefing Booklet submitted to Advisory Committee (Ex. 1005, 1)May 3, 2001: Sponsor’s video of Xyrem prescription process submitted to Advisory Committee (Ex. 1005, 2 ¶ 5, 14, 312; Ex. 1006)May 14, 2001: Federal Register Notice of Xyrem Advisory Committee Meeting (Ex. 1015, Col.

  • Brief profile of the company should cover all these areas with documentary evidences.

  • Failure is defined as worsening of renal function, cardiac output, or blood pressure and is attributed to the high sodium content of Xyrem and not to other causes.• Other causes of sleepiness have been ruled out or treated (including but not limited to obstructive sleep apnea, insufficient sleep syndrome, shift work, the effects of substances or medications, or other sleep disorders).• The dose does not exceed 9gm/day Approval will be for 12 months.

  • Caronia, whose salary was based on individual sales, nevertheless twice promoted Xyrem to doctors for unapproved uses.

  • A drug manufacturer’s sales representative, Caronia, was caught on tape touting to doctors the drug Xyrem, which the FDA had approved to treat narcoleptic patients, for unapproved uses.

Related to Xyrem

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