Item 8.01. Other Events.
On November 30, 2012, Endo Health Solutions Inc. announced that its subsidiary,
Endo Pharmaceuticals Inc., had filed suit against the U.S. Food and Drug
Administration (FDA) seeking a formal determination whether the original
formulation of OPANAŽ ER (oxymorphone HCl) was voluntarily removed from the
market in 2012 for reasons of safety involving the misuse of the drug; and FDA's
immediate suspension of any abbreviated new drug applications (ANDAs) for
generic versions of non-tamper resistant formulations of extended-release
oxymorphone HCl until FDA has made a determination as to whether the original
formulation of OPANA ER was withdrawn from sale for safety reasons.
A copy of the press release announcing the lawsuit is attached hereto as Exhibit
99.1.
Item 9.01. Financial Statements and Exhibits.
(a) Financial Statements of Business Acquired.
Not applicable.
(b) Pro Forma Financial Information.
Not applicable.
(c) Shell Company Transactions.
Not applicable.
(d) Exhibits.
Exhibit Number Description
99.1 Press Release