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).

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 [***]

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.

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.