Orphan Drug Product definition

Orphan Drug Product means a Licensed Product for a specific Indication for which the FDA has granted “Orphan-drug exclusive approval” as defined in 21 CFR Part 316 or which has been granted orphan drug exclusivity under similar regulations in any Major Market or other foreign jurisdiction.
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Orphan Drug Product means, with respect to a given Product sold in a given country of the Territory by MedImmune, its Affiliate or Sublicensee, a product sold by a Third Party in such country that is approved as an orphan drug under the Orphan Drug Action of 1983, as amended (or successor law or regulation), or equivalent regulatory approval granted by another Regulatory Authority.
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Examples of Orphan Drug Product in a sentence

  • We also have received Orphan Drug Product designation for GALE-301 and for GALE-302 from the FDA.Generally, if a product with an orphan drug designation subsequently receives the first regulatory approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the EMA or the FDA from approving another marketing application for the same drug for that time period.

  • We received Orphan Drug Product designations, from the FDA as well as orphan medicinal product designations, from the EMA, for GPS in AML and MPM.

  • We received Orphan Drug Product Designations from the U.S. Food and Drug Administration, or FDA as well as Orphan Medicinal Product Designations from the European Medicines Agency, or EMA, for GPS in AML and MPM, as well as Fast Track Designation for AML and MPM from the FDA.

  • In June 2016, the FDA granted two Orphan Drug Product designations for the treatment (including prevention of recurrence) of ovarian cancer: one for GALE-301 (E39) and one for GALE-302 (E39’).GALE-301 and GALE-302 in Ovarian CancerAccording to the NCI’s Surveillance, Epidemiology, and End Results, or SEER Program, new cases of ovarian cancer occur at an annual rate of 11.9 per 100,000 women in the United States, with an estimated 22,280 new cases and 14,240 deaths in 2016.

  • Our primary data source was the FDA Orphan Drug Product designation database.

  • During the current review cycle, the review team noted that balsalazide disodium (trade name Colazal) was designated an Orphan Drug Product on August 12, 2005 for the “treatment of pediatric patients with ulcerative colitis” [emphasis added] prior to the submission of this NDA for Giazo (balsalazide disodium in a tablet dosage form) on July 16, 2007.

  • Among the other benefits of Orphan Drug Product Designation are tax credits for certain research and a waiver of the BLA application user fee.A drug with Orphan Drug Product Designation may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received Orphan Drug Product Designation.

  • Central region by being asked to locate the major cities of the area on a map containing physical features and natural resources, but no place names.

  • We received Orphan Drug Product Designation from the FDA as well as Orphan Medicinal Product Designation from the EMA for GPS in AML and MPM, as well as Fast Track Designation from the FDA for AML, MPM, and NeuVax.

  • GPS was granted Orphan Drug Product Designations from the FDA as well as Orphan Medicinal Product Designations from the European Medicines Agency, or EMA, for GPS in AML, malignant pleural mesothelioma, or MPM, and multiple myeloma, or MM, as well as Fast Track Designation for AML, MPM, and MM from the FDA.

Related to Orphan Drug Product

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Generic Drug means a Prescription Drug that is medically equivalent to a Brand Name Drug as determined by the FDA. It meets the same standards as a Brand Name Drug for purity, safety, strength and effectiveness and is manufactured and sold under its chemical, common, or official name.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

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

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

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

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Licensed Compound means [***].

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • ANDA means Abbreviated New Drug Application.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).