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FDA responded to arguments in its proposed order denying drug firms’ requests to allow their RX polyethylene glycol 3350 products to remain on the market. Among the arguments, all rejected by FDA, was that a prescription PEG 3350 should be available for use by pediatric patients and that the product is not safe OTC for elderly consumers.
FDA drug center Director Janet Woodcock says the agency “concluded there is no genuine and substantial issues that precludes the withdrawal” of approval of ANDAs for generic Rx polyethylene glycol 3350 products. But FDA is allowing firms with the ANDAs 60 days to again argue their positions.
District judge says Apotex’s Bernard Sherman submitted results of experiments he never conducted to the Patent and Trademark Office; asserts that misconduct in the company’s suit against UCB constitutes an abuse of the patent system.
FTC Chair Ramirez backs Senate bill to make such agreements between brand and generic manufacturers presumptively illegal; attorney says companies should document the fair valuation of patent settlement deals before a judge.
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David Mashaal, VP, Global Bus. Dev.
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