Mylan Inc. has introduced 3 generic versions of existing drugs to the US market, including the first and only available intermediate dosages of transdermal fentanyl.
Expanding its existing offering of its fentanyl transdermal system 12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr, Mylan received final approval from the FDA for its Supplemental Abbreviated New Drug Application for 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr dosages.
“Mylan’s Fentanyl Transdermal System is the number 1 dispensed fentanyl transdermal system in the US, and now, for the first time, patients have access to additional dosing options through Mylan's launch of 3 new strengths," Mylan CEO Heather Bresch commented.
Transdermal fentanyl is indicated for the management of persistent, moderate-to-severe chronic pain.
The company also launched buprenorphine hydrochloride sublingual tablets, 2 mg and 8 mg, the generic version of Reckitt Benckiser's Subutex, as well as disulfiram tablets, 250 mg and 500 mg, the generic version of Odyssey Pharmaceutical's Antabuse, after receiving FDA approval of its ANDAs for both drugs.
Buprenorphine hydrochloride is indicated for the treatment of opioid dependence, while disulfiram tablet is meant to help patients manage chronic alcoholism and maintain a state of sobriety.