Acthar definition

Acthar means the Human Prescription Drug with the Proprietary Name “H.P. Acthar” approved by the Food and Drug Administration (“FDA”) under Application Number NDA022432 and presently sold with the Product NDC of 630004-8710, in whatever quantity and form it is or has been sold.
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Examples of Acthar in a sentence

  • Questcor’s H.P. Acthar Gel (repository corticotropin injection), is an injectable drug approved by the FDA for the treatment of 19 indications.

  • With respect to nephrotic syndrome, the FDA has approved Acthar to “induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.” Questcor is also exploring the possibility of developing other on-label indications and the possibility of pursuing FDA approval of additional indications not currently on the Acthar label where there is high unmet medical need.

  • CMS/DOJ/State Settlement The Plan will provide for the implementation of a settlement between Mallinckrodt, the United States, and the States resolving Acthar- related litigations and government investigations disclosed in the Company’s Form 10-K for 2019, including United States of America, et al., ex rel., ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, et al.

  • SCHEDULE 6.2 MANUFACTURING AND TESTING TRANSFER TIMETABLE AND PROJECT TEAM July 20, 2001 ▇▇▇▇▇ ▇▇▇▇▇ Senior Director, Business Development Aventis Behring ▇▇▇▇ ▇▇▇ ▇▇▇ Dear ▇▇▇▇▇, You had asked last week for a statement of intent from us regarding the site transfer plan for Acthar Gel.

  • Questcor’s primary product, Acthar, will add significant breadth and depth to Mallinckrodt’s growing portfolio of specialty brands, which includes EXALGO, Gablofen®, recently launched PENNSAID® 2% and XARTEMIS XR, and just acquired OFIRMEV, an IV form of acetaminophen on formulary in more than 2,350 hospitals across the U.S.

  • With respect to nephrotic syndrome, the FDA has approved Acthar to "induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus." Questcor is also exploring the possibility of developing other on-label indications and the possibility of pursuing FDA approval of additional indications not currently on the Acthar label where there is high unmet medical need.

  • At all relevant times, ARD distributed, marketed, and sold pharmaceutical products in the United States, including a drug sold under the trade name of H.P. Acthar Gel (“Acthar”).

  • The only animal-sourced materials used in the production of Acthar Bulk Concentrate, Lot YYYY, were porcine pituitary glands and porcine gelatin.

  • Questcor's H.P. Acthar Gel (repository corticotropin injection), is an injectable drug approved by the FDA for the treatment of 19 indications.