Agency IQ

MAY 17, 2024

At that time, the FDA would no longer be able to award new vouchers to companies, unless the product already had rare pediatric disease designation, and obtained approval before October 1, 2026. However, the FDA then approved another amifampridine product, Ruzurgi, in 2019 for the treatment of LEMS in pediatric patients.

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The Pharma Data

JANUARY 9, 2021

RECONCILIATION OF NON-GAAP MEASURES (unaudited) This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules and regulations.

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Government Vaccine Production Licensing 40

The Pharma Data

NOVEMBER 4, 2020

Securities and Exchange Commission Regulation G. VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. 1 (908) 892-2028 PR@amarincorp.com (media inquiries). .

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Production Trials FDA Disease 40