Nyvepria, a leukocyte growth factor, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
The approval was based on the review of comprehensive data demonstrating a high degree of similarity of Nyvepria to the reference product. The product will be available as 6mg/0.6mL preservative-free solution in single-dose prefilled syringes for subcutaneous injection. The Company expects to launch Nyvepria later this year.
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