PRINCETON, N.J., Sept 6 (Bernama-GLOBE NEWSWIRE) — SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its seventh ANDA approval from the US Food and Drug Administration (FDA).
The seventh approved ANDA is for Fosapreptant for Injection 150mg/vial. This drug product is used for treatment of cyclic vomiting syndrome and late-stage chemotherapy induced vomiting. This is a sub blockbuster product of over $350M US market size for 2018 according to IQVIA. RLD Emend®’s orange book patent expired on Sep 4th and SunGen obtained its ANDA approval on Sep 5th, which makes it is the first wave of all generic approvals for RLD Emend®.