Generics
Amneal reports availability of generic Chlorpromazine Hydrochloride Tablets USP and approval of Methylergonovine Maleate Tablets USP
13 September 2018 -

Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX ) reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) approval for its Abbreviated New Drug Application (ANDA) for Chlorpromazine Hydrochloride Tablets USP in 10 mg, 25 mg, 50 mg, 100 mg and 200 mg for the management of manifestations of psychotic disorders.

The company said the US FDA approved Chlorpromazine Hydrochloride Tablets USP in 10 mg, 25 mg, 50 mg, 100 mg and 200 mg will be launched in the US market with immediate effect.

For the 12 months ended July 2018, the US market for chlorpromazine hydrochloride tablets USP is estimated to be about USD207m in annual sales, according to IQVIA.

In addition, the company plans to market the approved generic version of Methergine Tablets USP, 0.2 mg (Methylergonovine Maleate Tablets USP, 0.2 mg ) shortly. This medication is used after childbirth to help stop bleeding from the uterus.

According to IQVIA, methylergonovine maleate tablets had annual US sales of approximately USD73m for the 12 months ending July 2018.

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