NEW YORK (TheStreet) -- Shares of Mallinckrodt Plc (MNK) are down 6.36% to $87.08 today after the specialty pharmaceuticals company criticized the FDA's reclassification of its generic attention-deficit hyperactivity disorder drug, the Wall Street Journal reports.
The Dublin-based company said the FDA has informed it that it has reason to believe that its methylphenidate hydrochloride tablets might not be therapeutically equivalent to Concerta, which is made by Johnson & Johnson's (JNJ) Janssen Pharmaceuticals., the Journal said.
"We believe that the FDA's actions are not supported by sound scientific evidence and not consistent with the best interests of patients," Mallinckrodt CEO Mark Trudeau said, adding, "Based on our review of Mallinckrodt's safety database and the conclusions the FDA has shared with the company, we remain confident in the safety of our methylphenidate ER products."
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Separately, TheStreet Ratings team rates MALLINCKRODT PLC as a Sell with a ratings score of D+. TheStreet Ratings Team has this to say about their recommendation:
"We rate MALLINCKRODT PLC (MNK) a SELL. This is driven by some concerns, which we believe should have a greater impact than any strengths, and could make it more difficult for investors to achieve positive results compared to most of the stocks we cover. Among the areas we feel are negative, one of the most important has been very high debt management risk by most measures."