FDA to review Banner's Bexarotene ANDA for CTCL skin cancer treatment

Oct 11 2011

Banner Pharmacaps Inc. ("Banner") has confirmed that its Abbreviated New Drug Application ("ANDA") for Bexarotene 75 mg soft gelatin capsules, a generic version of Targretin, has been accepted for review by the US Food and Drug Administration (FDA). Based upon available information, Banner believes that it is the first applicant to file an ANDA for Targretin containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act, and expects to qualify for 180 days of generic marketing exclusivity upon FDA approval.

"Banner's ANDA filing of Bexarotene marks an important milestone in the steady growth of our Rx portfolio," said Dr. Roger Gordon, President and CEO. "Knowing that our company is able to have a positive impact on the healthcare costs and treatment for cancer patients in the United States is inspiring and immensely rewarding."

Bexarotene capsules are used in the treatment of cutaneous T-cell lymphoma (CTCL skin cancer) and sold by Eisai Inc. under the brand name Targretin. Targretin is a registered trademark of Eisai Inc.