US EditionLupin gains tentative USFDA approval for Amifampridine Tablets - Express Pharma
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Lupin gains tentative USFDA approval for Amifampridine Tablets - Express Pharma
Lupin announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Amifampridine Tablets, 10 mg. This product would be manufactured at Lupin’s Goa facility in India. Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg of Catalyst Pharmaceuticals, and are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adult…
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