The US Food and Drug Administration (FDA) has granted SunGen Pharma, a privately held specialty pharmaceutical company that develops, contract manufactures, and sells pharmaceutical finished products, its seventh ANDA approval for Fosapreptant for Injection 150mg/vial, it was reported on Friday.
The product is utilised for the treatment of cyclic vomiting syndrome and late-stage chemotherapy induced vomiting. According to IQVIA, this is a sub-blockbuster product of more than USD350m market size for 2018. RLD Emend's orange book patent was withdrawn on 4 September and SunGen received its ANDA approval on 5 September. The company says that it is the first wave of all generic approvals for RLD Emend
Dr Isaac Liu, co-founder and co-CEO of the company, said, 'This first wave generic approval right after RLD patent expiration represents another key milestone by our own team. Our high quality development expertise are further demonstrated by the short approval timeline. It takes US FDA less than 10 months to approve this important ANDA.'
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