Mylan Pharms Generic Armodafinil Receives Approval in US
Apotex`s Generic Armodafinil Receives Approval in US
On Tuesday Lupin announced it had received the US Food and Drug Administration department's final approval for the product and is launching the product shortly. The product was filed from the company's Goa plant which recently received clearance from the US drug regulator.
Breckenridge Pharmaceutical, Inc. announced today that it has launched its ANDA for Armodafinil tablets (CIV) in 50mg, 150mg and 250mg strengths on November 28, 2016, after having received final approval by FDA. Armodafinil tablets is a generic version of Nuvigil® by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. Breckenridge and Cephalon entered into a confidential settlement which includes a license to market its ANDA effective 180 days after the initial launch of generic versions of Nuvigil®. Breckenridge is launching Armodafinil tablets with its partner Natco Pharma Limited, who is owner of the ANDA.
Lupin's Generic Armodafinil Receives Tentative Approval In US
Natco's Generic Armodafinil Receives Approval In US
Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Armodafinil Tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon's Nuvigil®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) and was awarded 180 days of marketing exclusivity for these strengths. Armodafinil Tablets are used to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift-work disorder.