This article was originally published in The Tan Sheet
Perrigo expects to ship immediately its OTC laxative polyethylene glycol 3350, powder to solution, following FDA approval of an abbreviated new drug application. Positioned as an equivalent to Schering-Plough Healthcare Products' MiraLAX laxative, the OTC drug will be sold under store-brand labels, the company notes. Perrigo had said it would be market-ready when Schering's exclusivity for the laxative drug expired Oct. 6 (1"The Tan Sheet" July 13, 2009)
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The firm prepares to be market-ready when Schering-Plough's exclusivity expires Oct. 6 for its OTC laxative MiraLAX. The expiry brings the "market formation date" and Perrigo expects "to be there," said Art Shannon, VP of investor relations and communications. Without exclusivity for the innovator, other firms can ask FDA to approve abbreviated new drug applications for equivalent products. Firms do not receive ANDA approval for the product until closer to Oct. 6, Shannon explained
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