FDA Extends PDUFA Date for Polyphenon(R) E Ointment to October 31, 2006.

Publication: PR Newswire

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COPYRIGHT 2006 PR Newswire Association LLC

FAIRFIELD, N.J., June 30 /PRNewswire-FirstCall/ -- BRADLEY PHARMACEUTICALS, INC. announced it has been advised by MediGene AG (Frankfurt, TecDAX: MDG), its licensor of Polyphenon(R) E Ointment, that the FDA has extended the deadline for the completion of its review of this product for treatment of external genital warts to October 31, 2006.

The PDUFA date was originally July 28, 2006. MediGene further advised Bradley 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...

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