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Lupin receives tentative U.S. FDA approval for fosaprepitant for injection

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).

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BALTIMORE — 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:

  • 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).

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