ALLEGAN, Mich., July 30 /PRNewswire-FirstCall/ — Perrigo
Company (Nasdaq: PRGO;TASE) announced that it has filed with the
U.S. Food and Drug Administration (FDA) an Abbreviated New Drug
Application (ANDA) for butoconazole nitrate vaginal cream, 2% and
that is has notified KV Pharmaceutical Company, the owner of the
New Drug Application (NDA) as well as FemmePharma, the listed owner
of the patent, of its ANDA filing. KV is a licensee under the
patent. Perrigo believes it is first-to-file on this
product.
On July 29, 2010, KV
Pharmaceutical Company filed suit in the United States District
Court for the District of Delaware, alleging patent infringement
to prevent Perrigo from proceeding with the commercialization of
this product. This action formally initiates the process under the
Hatch-Waxman Act. The suit also named FemmePharma as a
defendant as it had not agreed to join KV as a plaintiff in the
suit.
Gynazole·1® (butoconazole nitrate) vaginal
cream, 2% is indicated for the local treatment of vulvovaginal
candidiasis (infections cause by Candida). Prior to
its being discontinued in January
2009 due to manufacturing issues at KV, its annual sales
were approximately $28 million
annually, as measured by Wolters Kluwer Health.
Perrigo’s Chairman and CEO Joseph C.
Papa stated, “This filing is another example of our
investment in new products and expansion of our product portfolio.
The first to file status also reflects Perrigo’s continued focus on
being first to market with new products. As always, Perrigo is
committed to making quality healthcare more affordable for our
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