FDA approves SunGen’s generic Emend
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.”