Mylan Unveils First Generic Maxalt MLT Tabs

Mylan Inc.

today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) for Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg (base) and 10 mg (base), and Rizatriptan Benzoate Tablets, 5 mg (base) and 10 mg (base). These products are the generic versions of Merck's Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg (base) and 10 mg (base), and was awarded 180 days of marketing exclusivity.