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FDA approves Amneal's romidepsin injection, granting 180 days market exclusivity

Market News
04 Jun 2026
Proactive Investors
View Source
Bullish
pluang ai news

Amneal Pharmaceuticals received FDA approval for its romidepsin injection solution, a ready-to-use cancer treatment for cutaneous T-cell lymphoma. The product is eligible for Competitive Generic Therapy designation, giving Amneal 180 days of market exclusivity. This approval revives a previously withdrawn treatment and supports Amneal's focus on expanding its injectables business. The drug's U.S. sales reached about $78 million annually before withdrawal, indicating strong market potential.

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