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

  • Pertains to only the following five sections of the FPI: Boxed Warning, Indications and Usage, Dosage and Administration, Contraindications, and Warnings and Precautions.

  • If a product belongs to an established pharmacologic class, the following statement is required under the Indications and Usage heading in HL: “(Product) is a (name of established pharmacologic class) indicated for (indication)”.

  • If a product belongs to an established pharmacologic class, the following statement is required in the Indications and Usage section of HL: “(Product) is a (name of established pharmacologic class) indicated for (indication)”.

  • GSK had the ability and obligation to state prominently in the Indications and Usage section of its drug label that there is a lack of evidence that Zofran is safe for the treatment of morning sickness in pregnant women.

  • The FDA also announced that it would require a new Limitations of Use statement in the Indications and Usage section of the labels to “describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis.” Id.

  • Consistent with FDA’s practice of approving organ-based indications for transplant drug products, the Indications and Usage section of the approved labeling states, in part: ASTAGRAF XL is indicated for the prophylaxis of organ rejection in patients receiving a kidney transplant.

  • Changes to the Indications and Usage section: from “for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time” to “for the management of pain severe enough to require daily, around-the- clock, long-term opioid treatment and for which alternative treatment options are inadequate” (emphasis added).

  • The labeling regulations identify labeling sections where such discussion is appropriate (e.g., Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Use in Specific Populations).

  • Thus, because the mechanism of action of bupivacaine, the active ingredient in EXPAREL, is well known, and because the clinical studies of EXPAREL in bunionectomy and hemorrhoidectomy encompassed opposite ends of the spectrum of the human anatomy, FDA appropriately extrapolated from those studies and granted EXPAREL a broad postsurgical indication, as evidenced by the Indications and Usage section of the label.

  • In so doing, FDA rejected Dr. Simone’s proposed limitation to the Indications and Usage section and abandoned its proposal to include limiting language in the Warnings and Precautions section of the label.


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 has the meaning ascribed to it in Annex B.

  • Borrowing Availability means, as of any date of determination, the lesser of (i) the Maximum Amount and (ii) the Borrowing Base, in each case, less the sum of the aggregate Revolving Loan and Swing Line Loan then outstanding.

  • 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 (x) the Aggregate Revolving Loan Commitment at such time exceeds (y) the Dollar Amount of the Revolving Credit Obligations outstanding at such time.

  • LC Sublimit means $500,000,000.

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

  • Alternative Currency Sublimit means an amount equal to the lesser of the Aggregate Revolving Commitments and $200,000,000. The Alternative Currency Sublimit is part of, and not in addition to, the Aggregate Revolving Commitments.

  • Canadian Availability means, with respect to the Canadian Loan Parties, at any time, an amount equal to (a) the lesser of (i) the total Canadian Revolving Subcommitment of all Canadian Revolving Lenders and (ii) the Canadian Borrowing Base minus (b) the total Canadian Revolving Exposure of all Canadian Revolving Lenders.

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

  • 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 (a) with respect to a Borrowing of Term Loans or Revolving Credit Loans, $1,000,000 and (b) with respect to a Borrowing of Swingline Loans, $100,000.

  • 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.

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

  • Undrawn Availability at a particular date shall mean an amount equal to (a) the lesser of (i) the Formula Amount, or (ii) the Maximum Revolving Advance Amount, minus the Maximum Undrawn Amount of all Letters of Credit, minus (b) the sum of (i) the outstanding amount of Revolving Advances, plus (ii) amounts due and owing to any Borrower’s trade creditors which are outstanding sixty (60) days or more past the due date thereof.