Mylan launches first generic Focalin XR capsules
US generics major Mylan (NYSE: MYL) says its subsidiary Mylan Pharmaceuticals has launched dexmethylphenidate hydrochloride extended-release (ER) capsules, 30mg, which is the first generic version of Swiss pharma giant Novartis' (NOVN: VX) Focalin XR.
Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application containing a Paragraph IV patent certification for the generic product. The company received final approval from the US Food and Drug Administration for its ANDA for this product and was awarded 180 days of marketing exclusivity.
According to IMS Health, dexmethylphenidate hydrochloride ER capsules, 30mg, had US sales of about $67.34 million for the 12 months ending September 30, 2013. This product is a central nervous system stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged six years and older.
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