Mylan N.V. has launched additional dosages in the US of fentanyl rransdermal system 37.5, 62.5 and 87.5 mcg/hr, adding to its existing offering of fentanyl transdermal system 12, 25, 50, 75 and 100 mcg/hr. Mylan received final approval from the US Food and Drug Administration (FDA) for its supplemental abbreviated new drug application (ANDA) for its fentanyl transdermal system 37.5, 62.5 and 87.5 mcg/hr.

Fentanyl transdermal system’s existing strengths, including the 12, 25, 50, 75 and 100 mcg/hr presentations, had US sales of approximately $767 million for the 12 months ending September 30, 2014, according to IMS Health, and as reported by Mylan.

Mylan Inc. also has launched in the US buprenorphine hydrochloride sublingual tablets, 2 mg and 8 mg, which is the generic version of Reckitt Benckiser’s Subutex sublingual tablets. Mylan received final FDA approval for its ANDA for this product, which is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine hydrochloride sublingual tablets, 2 mg and 8 mg had US sales of approximately $107.8 million for the 12 months ending December 31, 2014, according to IMS Health, and as reported by Mylan.

Mylan also launched in the US disulfiram tablets USP, 250 mg and 500 mg, which is the generic version of Odyssey Pharmaceutical’s Antabuse. Mylan received FDA final approval for its ANDA for this product, which is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to the best advantage. Disulfiram Tablets USP, 250 mg and 500 mg, had US sales of approximately $16.4 million for the 12 months ending December 31, 2014, according to IMS Health, and as reported by Mylan.

Source: Mylan