Lupin announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg' (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta' (pegfilgrastim) 6 mg/0.6 mL injection.
The product will be manufactured at Lupin's Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval.
Armlupeg' is indicated for:
- Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
- Increase survival in patients acutely exposed to myelosuppressive doses of radiation.
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