US-based Banner Pharmacaps has submitted its Abbreviated New Drug Application (ANDA) for Bexarotene 75 mg soft gelatin capsules to be reviewed by the US Food and Drug Administration (FDA).
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Bexarotene capsules are used to treat cutaneous T-cell lymphoma (CTCL skin cancer) and are a generic version of Targretin.
Following FDA approval, the company expects to qualify for 180 days of generic marketing exclusivity.
Banner president and CEO Roger Gordon said the ANDA filing of Bexarotene would be an important milestone in the growth of the company’s Rx portfolio.
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