FDA approves SunGen’s generic Emend

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FDA approves SunGen’s generic Emend

By Sandra Levy - 09/24/2019

SunGen Pharma has received the Food and Drug Administration’s blessing for fosapreptant for injection in a dosage strength of 150mg/vial.

The product is the first generic of Merck’s Emend.

It is used for treatment of cyclic vomiting syndrome and late-stage chemotherapy induced vomiting.

The product had a market value of over $350 million for 2018, according to IQVIA.

“This first wave generic approval right after RLD patent expiration represents another key milestone by our own team” said Isaac Liu, SunGen co-founder and co-CEO. “Our high quality development expertise are further demonstrated by the short approval timeline. It took the FDA less than 10 months to approve this important ANDA.”

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