Bradley: FDA extends approval date for Polyphenon E genital wart ointment

By E. Janene Geiss

Philadelphia, June 30 - Bradley Pharmaceuticals, Inc. said Friday that it has been advised by MediGene AG, its licensor of Polyphenon E ointment, that the Food and Drug Administration has extended the deadline for the completion of its review of this product for treatment of external genital warts to Oct. 31.

The PDUFA date was originally July 28, officials said in a company news release.

MediGene said that this extension is a result of the FDA classification as a major amendment certain documents submitted by MediGene, which were requested earlier by the FDA.

On the PDUFA date, the FDA is expected to notify MediGene whether Polyphenon E ointment will be approved for marketing, approvable for marketing or not approvable for marketing, officials said.

MediGene is a Munich, Germany, pharmaceutical company.

Bradley is a Fairfield, N.J., specialty pharmaceutical company.

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