The company says it is waiting to hear from Mylan on whether the firms' merger agreement will be terminated as a result of the restatement. King continues to evaluate whether financial results prior to 2002 will require restatement.

FDA asks Endo to disseminate “corrective messages” to doctors who received the violative promotional materials, which the agency says omit risk information and contain unsubstantiated effectiveness claims.

Studies that look for differences in efficacy among members of the same drug class are only performed when necessary for approval, CDER Office of Medical Policy Director Temple tells DIA. While questioning the introduction of "follow-on" compounds, Temple also highlights AstraZeneca's success in achieving a more optimal dose for Nexium.