The Novartis ceo is finally acknowledging that ongoing problems with its diabetes med may stop the drugmaker from refiling its application with the FDA. In remarks earlier today, Dan Vasella says Novartis hasn’t yet completed discussions with the FDA about refiling requirements for Glavus, but it remains possible the drugmaker may not proceed with the filing at all, Dow Jones reports.

“It’s on the cards, that we won’t refile, but it’s also on the cards that we will,” he says. “But what is certainly clear, is that refiling without new data makes no sense.”

This comes after Novartis last fall found high doses of the diabetes pill are causing elevated liver enzyme levels, and that finding delayed the drug’s entry in Europe as a revision in prescribing info is made. For now, Novartis is still talking to the FDA about the types of clinical trials are needed to gain approval, the wire writes. But the drugmaker is reluctant to start a major trial now only to learn later that another major trial is needed, according to Dow Jones.

Last February, Novartis received an approvable letter for Galvus, but the safety study required by the FDA has been expected to delay Galvus until 2010, if the drug gets that far. This wasn’t the first setback - in 2006, the FDA delayed approval by three months waiting for more safety data after skin lesions had been seen in monkeys.

Of course, this is good news for Merck, which already sells a similar pill, Januvia, and so far hasn’t met with the same safety issues.

Hat tip to the WSJ Health blog