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FDA gives tentative nod for Lupin’s generic Emend

BY Sandra Levy

Lupin has received tentative approval from the Food and Drug Administration for fosaprepitant for injection in a 150 mg single-dose vial.

Lupin’s product is the generic version of Merck’s Emend for injection. 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; and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Fosaprepitant for injection, 150 mg single-dose vial, had a market value of approximately $312 million according to IQVIA March 2019 data.

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