Lannett Receives Approval For Dexmethylphenidate Hydrochloride Tablets, 2.5 mg, 5 mg And 10 mg
Published: Sep 26, 2017
PHILADELPHIA, Sept. 26, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it 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 Pharmaceuticals Corporation. 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).
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, successfully commercializing Dexmethylphenidate Hydrochloride Tablets, 2.5 mg, 5 mg, and 10 mg, and the planned launch of recently approved products, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.
Robert Jaffe Co., LLC
View original content with multimedia:http://www.prnewswire.com/news-releases/lannett-receives-approval-for-dexmethylphenidate-hydrochloride-tablets-25-mg-5-mg-and-10-mg-300525533.html
SOURCE Lannett Company, Inc.