Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Bexarotene 75mg Capsules, which is the generic version of Valeant's Targretin® Capsules. This product is indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
Mylan CEO Heather Bresch commented: "Mylan's launch of the first and only generic Targretin is another example of our commitment to expand access to high quality, more affordable medicines. The launch also strengthens Mylan's growing oncology franchise of more than 30 approved oncology treatments, and associated supportive care and diagnostic products in the U.S. We look forward to continue meeting patient, payor and provider needs in this space."
Bexarotene 75mg Capsules had U.S. sales of approximately $155.5 million for the 12 months ending March 31, 2015, according to IMS Health.
Currently, Mylan has 270 ANDAs pending FDA approval representing $107.2 billion in annual brand sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $33.3 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.