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news.Perrigo, a supplier of OTC pharmaceutical products, has acquired rights to Novel Laboratories’ pending ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit indicated for the cleansing of the colon as a preparation for colonoscopy in adults. The kit consists of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets.
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Novel Laboratories expects that it was first to file an ANDA containing a Paragraph IV Certification with the US FDA, and therefore the product is expected to be approved with 180 days of generic exclusivity.
The brand marketing exclusivity ends on September, 24, 2010. The company has not been sued. Under terms of the Perrigo/Novel agreement, Novel will manufacture the product exclusively for Perrigo.
Joseph Papa, chairman and CEO of Perrigo, said: “This acquisition is another example of Perrigo’s ongoing commitment to solidify our leadership position in the generic extended topical space, and to deliver quality, affordable healthcare products to retailers and consumers. Novel has a strong track record of bringing high-value first generic products into the market, and we look forward to our collaboration.”