Amneal Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application (ANDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg and has immediately initiated commercialization activities. According to IQVIA, the U.S. market for chlorpromazine hydrochloride tablets USP is estimated to be approximately $207 million in annual sales for the 12 months ended July 2018.
"Our large and diversified generic pipeline continues to deliver an industry leading number of approvals and launches in 2018," said Rob Stewart, President and CEO of Amneal. "The immediate launch of Chlorpromazine Hydrochloride Tablets, a potentially high-value opportunity, further enhances our generic portfolio and our commitment to provide patients with a more affordable treatment option."
The company also received approval for a generic version of Methergine Tablets USP, 0.2 mg (Methylergonovine Maleate Tablets USP, 0.2 mg ), which it expects to launch shortly. According to IQVIA, methylergonovine maleate tablets had annual U.S. sales of approximately $73 million for the 12 months ending July 2018.