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Mylan launches generic hypertension drug
PITTSBURGH — The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.
Mylan announced the approval and launch of candesartan cilexetil and hydrochlorothiazide tablets in the 16/12.5-mg, 32/12.5-mg and 32/25-mg strengths. Mylan said it was the first company to submit a complete regulatory approval application for the drug and is thus entitled to 180 days of market exclusivity in which to compete directly with the branded version.
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FDA grants orphan drug designation to Biodel drug for rare insulin disease
DANBURY, Conn. — The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.
Biodel announced that it had received orphan drug designation for glucagon to prevent hypoglycemia, or abnormally low blood sugar, in patients with CHI.