Saturday, 24 August 2019

Lupin receives tentative USFDA approval for Fosaprepitant for Injection

08 May 2019 | News

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

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).

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