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Wednesday, September 12, 2018
Amneal Pharmaceuticals: FDA approves ANDA for chlorpromazine hydrochloride
Amneal Pharmaceuticals announced it has received U.S. FDA approval on its Abbreviated New Drug Application 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 $207M in annual sales for the 12 months ended July 2018. The company also received approval for a generic version of Methergine Tablets USP, 0.2 mg, which it expects to launch shortly. According to IQVIA, methylergonovine maleate tablets had annual U.S. sales of approximately $73M for the 12 months ending July 2018.
https://thefly.com/landingPageNews.php?id=2789089
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