NEW DELHI: (Dec 1) Drug maker Lupin on Monday said it has received approval from the US health regulator for a biosimilar indicated for the treatment of neutropenia in cancer patients.
The US Food and Drug Administration (USFDA) 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) injection, the Mumbai-based firm said in a statement.
The product will be manufactured at the company’s biotech facility in Pune, which was inspected by the USFDA prior to approval, it added.
Source: PTI News
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