ACEON definition

ACEON means the product ACEON®, which is one of the subjects of the Amended and Restated License Agreement.
ACEON means all pharmaceutical preparations, in all dosage strengths, formulations and methods of administration, that contain ACEON API as the sole active ingredient for use in the Field, including without limitation those being marketed in the Territory as of the Effective Date under the trade name ACEON®.

Examples of ACEON in a sentence

  • The current applicant (Symplmed Pharmaceuticals LLC) became the owner of ACEON NDA 20184 on August 8, 2014.

  • In placebo-controlled U.S. clinical trials, the incidence of premature discontinuation of therapy due to adverse events was 6.5% in patients treated with ACEON and 6.7% in patients treated with placebo.

  • Among 1,012 patients in placebo-controlled U.S. trials, the overall frequency of reported adverse events was similar in patients treated with ACEON and in those treated with placebo (approximately 75% in each group).

  • Over 220 of these patients were treated with ACEON for at least one year.

  • Hyperkalemia: In clinical trials, 1.4% of the patients receiving ACEON and 2.3% of the patients receiving placebo showed serum potassium levels greater than 5.7 mEq/L.

  • XOMA hereby represents and warrants as of the Effective Date to, and covenants with, Servier that the representations, warranties and covenants made by XOMA in Section 14.4 are true and correct as of the Effective Date (in the case of Sections 14(e) through (g), with respect to ACEON and/or the ACEON API, as applicable, only).

  • Patients on diuretics, and especially those started recently, may occasionally experience an excessive reduction of blood pressure after initiation of ACEON therapy.

  • In U.S. controlled clinical trials, 1.4% of the patients receiving ACEON and 2.3% of patients receiving placebo showed increased serum potassium levels greater than 5.7 mEq/L.

  • In patients with severe congestive heart failure, where renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including ACEON, may be associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death.

  • The Parties shall work in a timely manner and cooperate with each other and with Abbott and the manufacturer of Licensed Products from API during the Transition Period to effect a smooth transition of the manufacturing and commercial activities in the Territory relating to ACEON to XOMA and to effectuate the First Commercial Sale of ACEON promptly.

Related to ACEON

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