Phim Sex Filme Porno PORNO GRÁTIS Filme Porno Phim Sex Mallinckrodt sues FDA over ADHD drug; reports Q4 loss [St. Louis Post-Dispatch] | Pharmacy News EU

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Mallinckrodt sues FDA over ADHD drug; reports Q4 loss [St. Louis Post-Dispatch]


Nov. 19Mallinckrodt Pharmaceuticals announced Wednesday it is suing the U.S. Food and Drug Administration for the agency’s "unlawful" reclassification of its attention-deficit hyperactivity disorder drug, methylphenidate ER.
The drug was previously considered, and approved, as a generic version of the branded drug Concerta until a week ago. But on Nov. 13, the FDA backtracked and told Mallinckrodt the drug "may not be therapeutically equivalent" and changed the classification of the drug. Mallinckrodt’s generic version originally received FDA approval on Dec. 28, 2012. The FDA maintains there are no safety concerns regarding the drug.
The company also sought a temporary restraining order against the agency to reinstate the drug’s classification as a generic on a temporary basis. The company filed the lawsuit in the U.S. District Court in Greenbelt, Md.
Mallinckrodt has maintained that the drug is a true substitute for Concerta.
During a earnings call today, Mallinckrodt CEO Mark Trudeau said of the 88 million dosages prescribed only 68 confirmed cases had a lack of efficacy.
Trudeau believes the loss of the drug as a generic can be offset by gains elsewhere. During the earnings call, Trudeau said, "We believe we have a number of opportunities to mitigate that impact so some extent."
Mallinckrodt Pharmaceuticals reported a fourth quarter loss of $352.4 million, or $4.14 per share, for the quarter ended Sept. 26, due in part to lower net income of the company’s global medical imaging unit and costs related the acquisition of Questcor Pharmaceuticals.
Mallinckrodt reported a previous fourth quarter net income of $33.5 million, or 58 cents a share.
Net sales for the fourth quarter increased nearly 45 percent to $789.3 million thanks to the addition of recently acquired drugs.
Mallinckrodt reported a fiscal 2014 loss of $319.3 million, or $4.92 per share, compared with a net income of $58.8 million, or $1.02 per share.
Net sales for the full year rose 15 percent to $2.5 billion.
Samantha Liss is a business reporter at the Post-Dispatch. Follow her on Twitter @samanthann and the business section @postdispatchbiz.
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