CorePharma to reopen under new ownership following Impax sale
This report analyzes the worldwide markets for Attention Deficit Hyperactivity Disorder (ADHD) Therapeutics in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World.
Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Dextroamphetamine Sulfate Extended-release Capsules, 5 mg, 10 mg, and 15 mg, a generic version of Amedra Pharmaceuticals LLC's Dexedrine®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in narcolepsy and attention deficit disorder with hyperactivity as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome.(1)
On February 19, 2016, the United States Food and Drug Administration (FDA) denied a June 27, 2013 Citizen Petition filed by Amedra Pharmaceuticals LLC’s (AMEDRA[1] or Company) relating to the Company’s Albenza (albendazole) Tablets, 200mg[2] (Citizen Petition or CP). In the CP, the Company requested the FDA to refrain from approving any abbreviated new drug applications (ANDAs) for a generic version of Albenza unless
Amedra`s Albenza (Albendazole) Chewable Tablets Approved in US For Helminthiasis