Orphan Drug Designation definition

Orphan Drug Designation means the special designation of Product by FDA’s Orphan Product Division which provides the Product with the opportunity to obtain additional market exclusivity from the date the drug receives FDA approval and also possible tax and regulatory approval benefits. The term “Orphan Drug Designation” shall include any foreign counterparts of the foregoing.

Orphan Drug Designation means designation by the EMEA as an orphan drug, a drug for a specified rare disease or condition, or the equivalent designation by a Regulatory Authority of any country of the Territory.

Orphan Drug Designation means the request for designation of AP1903 for the treatment of GvHD as an orphan drug under 21 C.F.R. §316.20 that has been granted by the FDA under 21 C.F.R. §316.24.

Examples of Orphan Drug Designation in a sentence

• INN-329, secretin, has received Orphan Drug Designation from the FDA.

• Orphan Drug Designation will provide market exclusivity in the U.S. for seven years, but only if (1) INN-329 receives market approval before a competitor using the similar peptide for the same indication, (2) Innovate is able produce sufficient supply to meet demand in the marketplace, and (3) another product with the same active ingredient is not deemed clinically superior.

• Orphan Drug Designation will provide market exclusivity in the U.S. for seven years, but only if (1) INN-108 receives market approval before a competitor using the same active compound for the same indication, (2) Innovate is able to produce sufficient supply to meet demand in the marketplace, and (3) another product with the same active ingredient(s) is not deemed clinically superior.

• Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration.

• In June 2018, the U.S. FDA granted Orphan Drug Designation to olinciguat for the treatment of patients with SCD.

More Definitions of Orphan Drug Designation

Orphan Drug Designation means a grant by the FDA of a request for designation under Section 526 of the Federal Food, Drug, and Cosmetic Act as amended by section 2 of the Orphan Drug Act (sections 525-528 (21 U.S.C. 360aa-360dd)) in the United States or any analogous grant by a Regulatory Authority in any other country in the Territory.

Orphan Drug Designation means the designation of the approval process, as granted by the FDA and/or EMEA;

Orphan Drug Designation means the FDA orphan drug designation dated January 10, 2000 received by Debiovision for the EVB Indication.

Orphan Drug Designation means the granting of special status by a country and/or government regulatory agency (such as the FDA, European Medicines Agency (EMA), Japanese Ministry of Health, Labour and Welfare (MHLW), or Therapeutics Goods Administration (TGA) to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor under the U.S. Orphan Drug Act (ODA) or any foreign equivalent(s) to this law enacted by other countries including but not limited to Australia, member countries of European Union, and Japan.

Orphan Drug Designation means a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance.

Orphan Drug Designation means the designation that the MHLW may grant if (1) the number of patients who may use the drug are less than 50,000 in Japan, (2) the drug is indicated for the treatment of patients with serious diseases, including the difficult-to-treat diseases and (3) there is no appropriate alternative drug or treatment, or higher efficacy or safety is expected compared with existing products. Orphan Drug Designation provides an extension of the re-examination period up to 10 years. In case the MHLW or the government of Japan revise or replace such system for orphan drugs, the revised or similar system shall apply.

Orphan Drug Designation means designation under the U.S. Orphan Drug Act, as amended, or any successor statute, of a Product for treatment of mesothelioma.