Definitions

from Wiktionary, Creative Commons Attribution/Share-Alike License

  • n. A growth hormone-releasing hormone analogue.

Etymologies

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Examples

  • Its most advanced program is tesamorelin, which is concluding a confirmatory Phase 3 clinical trial for a serious metabolic disorder known as HIV-associated lipodystrophy.

    Marketwire - Breaking News Releases

  • These assumptions include, but are not limited to, that ANVISA and other regulatory agencies will approve tesamorelin for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy, that no additional clinical trials will be required by ANVISA or other regulatory agencies in order to approve tesamorelin, that and that tesamorelin will be accepted by the marketplace as a treatment of HIV-associated lipodystrophy if approved by ANVISA.

  • These risks and uncertainties include, but are not limited to, the risk that ANVISA and other regulatory agencies do not approve tesamorelin for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy, or that ANVISA or other regulatory agencies require additional clinical studies prior to making any decision regarding the approval or non-approval of tesamorelin.

  • This forward-looking information includes, but is not limited to, information regarding the potential approval of tesamorelin by ANVISA and other regulatory agencies for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy and the size of the Brazilian market.

  • "This is the first regulatory application for tesamorelin in Latin America and we are excited about the potential of this very important market," said Mr. John-Michel T.

  • Additional applications for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy are currently under review with regulatory agencies in Europe, Canada and Israel.

  • Theratechnologies signed a distribution and licensing agreement with an affiliate of Sanofi on December 6, 2010, granting them exclusive commercialization rights for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East.

  • Theratechnologies submitted an NDA to the FDA on May 29, 2009, for tesamorelin, an analogue of the human growth hormone releasing factor proposed for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.

    The Earth Times Online Newspaper

  • The Company's growth strategy is centered on the commercialization of tesamorelin in the United States and in other markets for HIV-associated lipodystrophy, as well as the development of clinical programs for tesamorelin in other medical conditions.

    The Earth Times Online Newspaper

  • As a result of this postponement, the FDA has indicated that the action goal date, which is the target date for the FDA to complete its review of the tesamorelin NDA, will be extended to July 27, 2010.

    The Earth Times Online Newspaper

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