Orphan Drug Status definition

Orphan Drug Status means the period during which the Product is approved as an orphan drug.
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Orphan Drug Status means the grant of seven years of marketing exclusivity for a Product pursuant to the Orphan Drug Act of 1983. 1.13 *. * Confidential Treatment Requested
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Orphan Drug Status is an exclusive approval to market a therapeutic for the treatment of a human fibrotic disease based upon orphan drug status under the Orphan Drug Act of 1983 in the United States (Pub.L. 97-414, Jan.4, 1983, 96 Stat. 2049) or any corresponding or similar non-U.S. statutes, granted by the U.S. Food and Drug Administration (“FDA”), the Committee on Proprietary Medicinal Products (“CPMP”) or other Regulatory Agencies in the Territory to InterMune for the anti-fibrotic uses of Pirfenidone for such disease.
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Examples of Orphan Drug Status in a sentence

  • Additionally, the FDA has granted Orphan Drug Status and a Rare Pediatric Disease Designation to MC-1 for the treatment of PNPO deficiency.

  • Orphan drug statusThe applicant requested Orphan Drug Status in accordance with Article 4 adecies no.

  • MDNA55 has secured Orphan Drug Status from the United States Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) as well as Fast Track Designation from the FDA for the treatment of rGBM and other types of high grade glioma.

  • Its lead investigational therapy Multikine® (Leukocyte Interleukin, Injection) is currently in a pivotal Phase 3 clinical trial involving head and neck cancer, for which CEL-SCI has received Orphan Drug Status from the U.S. FDA.

  • Orphan Drug Status The Corporation announced, in November 2016, that the European Medicines Agency (“EMA”) had granted orphan drug designation status to IMV’s MVP-S in ovarian cancer.

  • NurOwn® has received Fast Track designation from the FDA in ALS and has additionally been granted Orphan Drug Status by the FDA and the EMA.

  • The Company has secured Orphan Drug Status from the FDA and the EMA as well as Fast Track Designation from the FDA.MDNA55 is delivered locally to the site of the tumor using convection enhanced delivery (“CED”) technology, a drug delivery technique for localized administration of MDNA55 into brain tumors.

  • AveXis Receives Orphan Drug Status from the US Food and Drug Administration (FDA) for chariSMA for the Treatment of Spinal Muscular Atrophy.

  • If the FDA declines to allow the assignment of any of ENTREMED's Investigational New Drug and/or Orphan Drug Status application(s) to CELGENE, for whatever reason, then ENTREMED's rights under such application(s) will be included in this Agreement as ENTREMED EXISTING TECHNOLOGY RIGHTS and will be licensed to CELGENE in accordance with Section 2 of this Agreement.

  • ENTREMED shall take all further steps necessary or helpful to assign to CELGENE all Orphan Drug Status and Investigational New Drug applications filed by ENTREMED as of the EFFECTIVE DATE, as set forth in Appendix C.


More Definitions of Orphan Drug Status

Orphan Drug Status means an award of marketing exclusivity under the Orphan Drug Act of 1983 in the United States or any comparable Law in an applicable jurisdiction that provides a period of marketing exclusivity, which designation has not been revoked or expired.
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Orphan Drug Status means, with respect to a Licensed Product, that (i) the Secretary of the FDA has (1) approved an application filed pursuant to section 505(b) of the Federal Food, Drug and Cosmetic Act (“FD&C Act”), (2) issued a certification under section 507 of the FD&C Act, or (3) issued a license under section 351 of the Public Health Service Act for such Licensed Product designated under section 526 of the FD&C Act for a rare disease or condition, and (ii) the Licensed Product has obtained market exclusivity under section 505A of the Food and Drug Administration Modernization Act of 1997.
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Related to Orphan Drug Status

  • orphan means a child who has no surviving parent caring for him or her;

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Criminal drug statute means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, possession or use of any controlled substance.

  • ANDA means an abbreviated new drug application filed with the FDA, pursuant to its rules and regulations (or any equivalent or replacement mechanism).

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Covered drug means any prescription drug that:

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Prescription drug means any drug required by federal law or regulation to be dispensed only

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.