Lupin gets tentative USFDA nod for Fosaprepitant injection

Fosaprepitant for injection is a generic version of Merck Sharp & Dohme Corp's Emend for injection in the same strength.

New Delhi: Drug firm Lupin Tuesday said it has received the tentative nod from the US health regulator to market its Fosaprepitant for injection, used to prevent nausea and vomiting associated with cancer chemotherapy.

The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market its Fosaprepitant for injection in the strength of 150 mg single-dose vial, Lupin said in a statement.

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The product is a generic version of Merck Sharp & Dohme Corp's Emend for injection in the same strength, it added.

As per IQVIA MAT March 2019 data, Fosaprepitant for injection, 150 mg single-dose vial, had annual sales of around USD 312 million in the US market, Lupin said.

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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 including high-dose cisplatin, it added.

The drug is also indicated for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, Lupin said.

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