FDA approves Mylan's generic Maxalt MLT tablet
PITTSBURGH — Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and rizatriptan benzoate tablets, 5 mg and 10 mg. 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 and 10 mg, and was awarded 180 days of marketing exclusivity.
"Mylan's immediate launch of the first generic rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and the company's simultaneous launch of rizatriptan benzoate tablets, 5 mg and 10 mg, further demonstrates our commitment to continue expanding access to high-quality medicines for patients who need them in the U.S. and around the world. We look forward to continue growing our portfolio of more than 1,100 generic pharmaceutical products to further support this cause," said Mylan CEO Heather Bresch.
Currently, Mylan has 183 ANDAs pending FDA approval, representing $79.9 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $20.8 billion in annual brand sales, for the 12 months ended June 30, 2012, according to IMS Health.