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The Legislative Architecture Behind the Books The Hatch-Waxman Act (1984) and the Orange Book The Drug Price Competition and Patent Term Restoration Act of 1984, universally called the Hatch-Waxman Act, created the modern generic drug approval pathway and made the Orange Book what it is today

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Subcutaneous injections may lead to mild local reactions such as redness, swelling, tenderness, or itching at the site, while some users experience temporary fatigue, headaches, or light nausea