Lannett Receives Approval for Dexmethylphenidate Hydrochloride Tablets

Lannett has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Dexmethylphenidate Hydrochloride Tablets, 2.5 mg, 5 mg, and 10 mg, the therapeutic equivalent to the reference listed drug, Focalin Tablets, 2.5 mg, 5 mg, and 10 mg, of Novartis. For the 12 months ended July 2017, total U.S. sales of Dexmethylphenidate Hydrochloride Tablets, 2.5 mg, 5 mg, and 10 mg, at Average Wholesale Price (AWP) were approximately $34 million, according to IMS.

"The approval for Dexmethylphenidate Hydrochloride Tablets is our eighth thus far in 2017 and comes less than 24 months after our filing of the related ANDA," said Arthur Bedrosian, chief executive officer of Lannett. "Despite several current competitors, the market for the product is growing. We anticipate launching our Dexmethylphenidate Hydrochloride Tablets in the next several months. This, along with the expected launch of other recently approved products, gives us confidence in a solid fiscal 2018."

Dexmethylphenidate Hydrochloride Tablets are used for the treatment of attention deficit and hyperactivity disorder (ADHD).