Orphan Designation definition

Orphan Designation means the designation of a drug as a drug for a rare disease or condition pursuant to Section 526 of the Act.

Orphan Designation means the grant by FDA of a request for orphan-drug designation under Section 526 of the Act, as amended (or its successor regulation), for a drug for a particular Orphan Indication.

Orphan Designation means any treatment of a disease which afflicts less than 50,000 patients per year in the Territory and /or the use in such patients and that meets the criteria for orphan designation application established by the governing health care authority in the Territory other than the Field.

Examples of Orphan Designation in a sentence

• RUSH shall assist and cooperate with ACORDA in the submission of any letters or other documents to the FDA required or requested in connection with the change in ownership of the Rush Orphan Designation from RUSH to ACORDA.

• To the extent not previously assigned to ACORDA, RUSH hereby conveys, assigns and transfers to ACORDA, free and clear of all claims, liens and encumbrances and contractually imposed restrictions, all right, title and interest in and to the Rush Orphan Designation.

• Previously, the FDA granted Orphan Designation to Acthar for the treatment of IS.

• OSIRIS grants to JCR, during the term of this Agreement, a right of first negotiation to obtain from OSIRIS the exclusive right, in the Territory, to develop, register, use, make, have made, import, export, offer to sell, sell and have sold Products for a use that has an Orphan Designation in the Territory.

• DATE SUBLICENSE GRANTED % OF CONSIDERATION PAYABLE [**] [ **] [**] [ **] [**] [ **] 1 Orphan Designation (or sometimes “orphan status”) is a special status that is granted to a drug or biological product to treat a rare disease or condition upon request of the Company.

• For purposes of the Agreement, Orphan Designation shall mean that the FDA or other foreign regulatory body has granted the Company market exclusivity with respect to the Licensed Product.

• Additionally, GW has received Fast Track Designation from the FDA and Orphan Designation from the European Medicines Agency for Epidiolex for the treatment of Dravet syndrome.

• As a result of this Orphan Designation, if Questcor is successful in obtaining FDA approval for the IS indication, Questcor believes that it will also qualify for a seven-year exclusivity period during which the FDA is prohibited from approving any other adrenocorticotropic hormone (ACTH) formulation for IS unless the other formulation is demonstrated to be clinically superior to Acthar.

• The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for EPIDIOLEX for the treatment of LGS, Dravet syndrome, West syndrome and TSC.

• Feldman group BAG3 is implicated in many diseases including heart failure, cardiac amyloidosis and CNS disorders Background: BAG3-associated Dilated Cardiomyopathy (DCM) The BAG3 Population: Potential for Orphan Designation Source: Ziaeian and Fonarow 2016; Judge et al., 2008; Hershberger et al., 2010; Haas et al., 2015; Knezevic et al., 2015.

More Definitions of Orphan Designation

Orphan Designation means the orphan designation EU/3/16/1778 granted by the European Commission on 18 November 2016.

Orphan Designation means orphan status provided to pharmaceuticals, biologics, medical devices and medical food intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders meeting certain criteria in the United States specified in the Orphan Drug Act and FDA’s implementing regulations at 21 CFR Part 316, and including foreign equivalents thereof, including, criteria provided by the European Medicine’s Agency’s Committee for Orphan Medicinal Products (COMP), the Australian Government’s Department of Health, Therapeutic Goods Administration, and the Ministry of Health, Labour and Welfare of Japan.