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Stock Market & Financial Investment News

News Breaks
April 9, 2014
06:02 EDTMNKMallinckrodt upgraded to Buy from Neutral at UBS
News For MNK From The Last 14 Days
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November 19, 2014
09:16 EDTMNKOn The Fly: Pre-market Movers
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07:01 EDTMNKMallinckrodt reports Q4 adjusted EPS $1.68, consensus $1.41
Reports Q4 revenue $789.3M, consensus $757.86M.
November 18, 2014
15:21 EDTMNKNotable companies reporting before tomorrow's open
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November 14, 2014
17:27 EDTMNKPaulson & Co. gives quarterly update on stakes
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09:51 EDTMNKMallinckrodt management to meet with Oppenheimer
Meeting to be held in Europe on November 20 hosted by Oppenheimer.
November 13, 2014
10:44 EDTMNKMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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08:20 EDTMNKMallinckrodt could be down $6-$8 on FDA reclassification, says UBS
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06:11 EDTMNKMallinckrodt responds to FDA expected reclassification of methylphenidate ER
Mallinckrodt has been informed by the FDA that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release, or ER, tablets, USP may not be therapeutically equivalent to the category reference drug Concerta. As a result, the agency indicated that it has reclassified Mallinckrodt’s ANDA 202608 for methylphenidate ER dosage strengths of 27mg, 36 mg and 54 mg from AB to BX. The agency said that this change was based on the application of its new Draft Guidance for determining bioequivalence of methylphenidate hydrochloride products just published on November 6, 2014. Although the Draft Guidance has an open comment period through January 5, 2015, the agency nevertheless confirmed that this change would be reflected on November 13, 2014 in the on-line Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Mallinckrodt strongly believes its methylphenidate ER products are safe and effective when used in accordance with the approved labels. Mark Trudeau, president and CEO of Mallinckrodt stated, “We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients." Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA, and in the 21 months since launch more than 88M doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug to the company’s methylphenidate ER products.

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