Indications and Usage definition

Indications and Usage means the section of the FDA-approved labeling for a drug product that states such drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a recognized disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition, as set forth in 21 C.F.R. Section 201.57(c)(2).
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Indications and Usage means the section of the FDA-approved labeling for a drug product that states such drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a recognized disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition, as set forth in 21 C.F.R. Section 201.57(c)(2). “Intellectual Property” shall mean intellectual property or proprietary rights of any kind anywhere in the world, including any rights in or to Patents, Trademarks, Copyrights and Trade Secrets, and database rights, whether U.S. or non-U.S, together with all rights to claim priority from such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world.
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Indications and Usage means the section of the FDA-approved labeling for a drug product that states such drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a recognized disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition, as set forth in 21 C.F.R. Section 201.57(c)(2). “Boxed Warning” means a contraindication or serious warning required by the FDA to be presented in a box within the approved labeling of a drug product, as set forth in 21 C.F.R. Sections 201.57(a)(4) and 201.57(c)(1). Tranche C Term Loans Lenders and their respective Applicable Commitments: Lender Applicable Commitment Oaktree-TCDRS Strategic Credit, LLC [***] Oaktree-Xxxxxxx Multi-Strategy, LLC [***] Oaktree-TBMR Strategic Credit Fund C, LLC [***] Oaktree-TBMR Strategic Credit Fund F, LLC [***] Oaktree-TBMR Strategic Credit Fund G, LLC [***]
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Examples of Indications and Usage in a sentence

  • Prescribing physicians and health care practitioners are referred to their locally approved product label for bortezomib regarding Indications and Usage, Contraindications, Warnings, and Precautions.

  • Dr. Simone recommended narrowing the Indications and Usage section of the PI to state that EXPAREL was approved only for “postoperative analgesia following hemorrhoidectomy and bunionectomy,” but FDA elected not to adopt this limitation.

  • Bipolar ManiaThe efficacy and safety of quetiapine in the treatment of mania in children and adolescents ages 10 to 17 years with bipolar I disorder was demonstrated in a 3-week, double-blind, placebo-controlled, multicenter trial [see Indications and Usage (1.2), Dosage and Administration (2.3), Adverse Reactions (6.1), and Clinical Studies (14.2)].

  • Indications and Usage: Rheumatoid arthritisDosage and Administration: The recommended adult dosage of iguratimod is one 25 mg tablet taken orally once daily after breakfast for at least four weeks, after which the dosage should be increased to one 25 mg tablet taken twice daily (after breakfast and after dinner).

  • FDA also notes that the Indications and Usage statement in Otsuka’s labeling “has always listed ‘Treatment of Tourette’s Disorder’ as the indication,” and that the indication was “unchanged when the approval letter was corrected.” (FDA 000283-84).

  • Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Indications and Usage (1.1, 1.2)] .

  • HiPEAC addresses the design and implementation of high-performance commodity computing devices in the 10+ year horizon, covering both the processor design, the optimising compiler infrastructure, and the evaluation of upcoming applications made possible by the increased computing power of future devices.

  • The following Limitation of Use was included in the Indications and Usage section of the labeling: No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established.

  • Approved Pediatric IndicationsSchizophreniaThe efficacy and safety of risperidone in the treatment of schizophrenia were demonstrated in 417 adolescents, aged 13 to 17 years, in two short-term (6 and 8 weeks, respectively) double-blind controlled trials [see Indications and Usage (1.1), Adverse Reactions (6.1), and Clinical Studies (14.1)].

  • The decision to prescribe atypical antipsychotic medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms [see Indications and Usage (1.3)].Symbyax® (olanzapine and fluoxetine hydrochloride) is a trademark of Eli Lilly company.Medication Guide Olanzapine Tablets USP (oh lan' za peen)Read the Medication Guide that comes with olanzapine tablets before you start taking them and each time you get a refill.


More Definitions of Indications and Usage

Indications and Usage. Myocardial Imaging: Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Cardiolite® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g. exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling). Contraindications: None known.
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Related to Indications and Usage

  • Facility Usage means, at the time in question, the aggregate amount of outstanding Loans and LC Obligations at such time.

  • L/C Sublimit means an amount equal to $5,000,000. The L/C Sublimit is part of, and not in addition to, the Aggregate Commitments.

  • Borrowing Availability means as of any date of determination the Maximum Amount less the sum of (i) the Revolving Loan and Swing Line Loan then outstanding and (ii) the Reserves as then in effect.

  • Revolving Facility Usage means at any time the sum of the outstanding Revolving Credit Loans, the outstanding Swing Loans, and the Letter of Credit Obligations.

  • Revolving Credit Availability means, at any particular time, the amount by which the Aggregate Revolving Loan Commitment at such time exceeds the Revolving Credit Obligations outstanding at such time.

  • Replacement Revolving Commitments shall have the meaning assigned to such term in Section 2.22.

  • Replacement Revolving Facility Effective Date shall have the meaning assigned to such term in Section 2.21(l).

  • LC Sublimit means $500,000,000.

  • Sublimit means the aggregate amount of Warehousing Advances (expressed as a dollar amount or as a percentage of the Warehousing Commitment Amount) that is permitted to be outstanding at any one time against a specific type of Eligible Loan.

  • Replacement Revolving Facility has the meaning assigned to such term in Section 9.02(c)(ii).

  • Committed Amount shall have the meaning assigned thereto in the Pricing Side Letter.

  • Replacement Revolving Facility Commitments shall have the meaning assigned to such term in Section 2.21(l).

  • Revolver Usage means, as of any date of determination, the sum of (a) the amount of outstanding Advances, plus (b) the amount of the Letter of Credit Usage.

  • Applicable Policies means the policies, bylaws, directives, regulations, guidelines, codes of conduct, rules, systems and procedures of AHS listed in Schedule “F” attached.

  • Alternative Currency Sublimit means an amount equal to the lesser of the Aggregate Commitments and $50,000,000. The Alternative Currency Sublimit is part of, and not in addition to, the Aggregate Commitments.

  • Canadian Availability means (a) the lesser of (x) the Canadian Sublimit and (y) the sum of (i) the Canadian Borrowing Base plus (ii) solely to the extent the total Revolving Exposure relating to the Canadian Borrower exceeds the Canadian Borrowing Base, the US Availability (calculated without giving effect to any Canadian US Borrowing Base Utilization), minus (b) the total Revolving Exposure relating to the Canadian Borrower.

  • Required Availability means Excess Availability and unrestricted cash and Cash Equivalents in an amount of not less than $5,000,000.

  • Canadian Borrowing Base means, at any time, an amount in Dollars equal to:

  • Available Commitments shall refer to the aggregate of the Lenders’ Available Commitments hereunder.

  • Total Revolving Credit Outstandings means the aggregate Outstanding Amount of all Revolving Credit Loans, Swing Line Loans and L/C Obligations.

  • Minimum Borrowing Amount means (i) for Revolving Loans, $5,000,000, and (ii) for Swingline Loans, $1,000,000.

  • Swingline Sublimit means an amount equal to the lesser of (a) $15,000,000 and (b) the Revolving Facility. The Swingline Sublimit is part of, and not in addition to, the Revolving Facility.

  • Revolving Loan Availability means, at any time, the Revolving Loan Limit minus the Revolving Loan Outstandings.

  • Permitted Amount means, on any date, an amount equal to 3.5 times Adjusted EBITDA as of the most recent fiscal quarter for which financial statements of the Company are internally available immediately preceding such date.

  • L/C Issuer Sublimit means with respect to each L/C Issuer, such amount as may be separately agreed between such L/C Issuer and the Borrower from time to time (with specific notice of such amount, and any change thereto, with respect to each L/C Issuer being promptly communicated to the Administrative Agent), provided that the L/C Issuer Sublimit with respect to any Person that ceases to be an L/C Issuer for any reason pursuant to the terms hereof shall be $0 (subject to the Letters of Credit of such Person remaining outstanding in accordance with the provisions hereof).

  • Swingline Facility means the swingline facility established pursuant to Section 2.2.