Pepcid Complete generic debuts
This article was originally published in The Tan Sheet
Perrigo expects to ship its OTC Famotidine Complete chewable tablets in the third quarter of 2008 following FDA final approval of its abbreviated new drug application, the Allegan, Mich.-based firm says Feb. 12. The product (famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg) is comparable to Johnson & Johnson/Merck's Pepcid Complete acid reducer/antacid medicine and will be marketed under store brand labels, Perrigo notes. It expects marketing exclusivity as the first company to file a complete ANDA with a Paragraph IV certification, but has not indicated what the duration will be. "This final approval reflects our continuing investment in new products," CEO Joseph C. Papa says in a release. The launch follows a federal court ruling in 2007 that invalidated a key patent for Pepcid Complete (1"The Tan Sheet" June 11, 2007, p. 5)...
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