Lupin receives tentative USFDA approval for Fosaprepitant for injection
(07 May 2019)
Pharma major Lupin announced that it has received tentative
approval for its Fosaprepitant for Injection, 150 mg Single-Dose Vial, from the United States Food and Drug Administration (FDA) to market a generic version of Emend for Injection, 150 mg Single-Dose Vial, of Merck Sharp & Dohme Corp. (Merck).
Lupin's Fosaprepitant for Injection, 150 mg Single-Dose Vial, is the generic version of Merck's Emend for Injection, 150 mg Single-Dose Vial. It is indicated for adults in combination with other antiemetic agents, for the prevention of:
i) acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
ii) delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).