Amneal gets FDA nod for generic Exelon patch

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Amneal gets FDA nod for generic Exelon patch

By Sandra Levy - 01/15/2019
Amneal has received regulatory approval for its first transdermal generic product. The company has received Food and Drug Administration approval for its generic Exelon patch (rivastigmine transdermal system). The generic of Novartis' branded product is approved in 4.6 mg/24 hours, 9.5 mg/24 hours and 13.3 mg/24 hours dosage strengths.

Amneal's generic Exelon patch is indicated to treat mild, moderate and severe memory problems associated with Alzheimer’s disease.

"We are pleased to receive approval on the company's first transdermal product, which demonstrates our commitment to develop and bring to market complex generic products," Amneal president and CEO Rob Stewart said. "Our diverse pipeline of approximately 220 products is expected to deliver additional complex product approvals this year and help us achieve our goal of launching up to 50 generic products in 2019."

Rivastigmine transdermal system had a market value of approximately $225 million for the 12 months ended November 2018, according to IQVIA.

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