Lupin receives tentative USFDA approval for Fosaprepitant for Injection

Lupin Limited (Lupin) 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:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
• delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Fosaprepitant for Injection, 150 mg Single-Dose Vial, had annual sales of approximately USD 312 million in the US (IQVIA MAT March 2019).