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FDA

FDA OKs single-dose, self-controlled delivery device for Acthar Gel

March 7, 2024

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FDA has approved a new single-dose prefilled SelfJect Injector of Acthar Gel (repository corticotropin injection) for SC administration. Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children <2 years of age; for the treatment of MS exacerbations in adults; and may be used for the following conditions: rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and edematous state.

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