Teva to Try Again With Agilect

Shares of Teva Pharmaceutical Industries (TEVA) sagged Monday as investors digested the latest setback in the company's attempt to sell a treatment for symptoms of Parkinson's disease.

On Friday, the Food and Drug Administration issued a letter delaying approval of the drug, which is called Agilect. This is the second such delay since last year. Teva issued only a brief comment Friday, declining to provide any details about the delay, the FDA's concerns and the timetable for meeting the agency's questions about the drug.

"While the letter reiterates the FDA's position that the application is approvable, there remain a number of issues that Teva believed it had resolved with its submissions, but as to which the FDA continues to have concerns," the company said. "Teva intends to meet promptly with the FDA and to work closely with the agency to resolve these issues."

Teva's announcement didn't hit the stock Friday, but on Monday, shares of the Israel-based company fell 89 cents, or 2.7%, to $32.37 on heavier-than-average volume.

Teva specializes in generic drugs, and it recently bid $7.4 billion to acquire Miami-based Ivax (IVX) in an effort to regain the title of world's largest generic-drug company. That title was recently taken by the Sandoz unit of Novartis (NVS) after the parent company spent $8.3 billion for a German generic drug company and a U.S. generic drug company.

Already the company has a popular brand-name drug, Copaxone, for multiple sclerosis. The company is trying to bolster its brand-name neuroscience offerings with Agilect, which has been approved for use in European Union countries.

The company is seeking U.S. approval for Agilect as a single treatment for patients in the early stages of the progressive neurological disorder, as well as part of a combination with a stronger drug, levodopa, for people in advanced stages. The drugs are used to reduce symptoms such as tremors and loss of balance.