Amneal gets FDA approval for two generics
Amneal Pharmaceuticals has received the Food and Drug Administration’s blessing for chlorpromazine hydrochloride tablets in 10 mg, 25 mg, 50 mg, 100 mg and 200 mg dosage strengths.
Chlorpromazine hydrochloride tablets had a market value of approximately $207 million for the 12 months ended July 2018, according to IQVIA.
“Our large and diversified generic pipeline continues to deliver an industry leading number of approvals and launches in 2018,” Amneal president and CEO Rob Stewart, said. “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.”
In a separate development, Amneal also received the FDA’s nod for a generic version of methergine tablets, 0.2 mg (methylergonovine maleate tablet, 0.2 mg ).
Methylergonovine maleate tablets had a market value of approximately $73 million for the 12 months ending July 2018, according to IQVIA data.
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