Japanese Diabetes Drug May Take Four Years to Make it to USA

A drug company can decide which countries it wants to introduce its drugs into first. Here in the United States, we assume drug companies will introduce them here first. Usually American drug companies introduce drugs in the United States. But drug companies in Europe often apply for approval there. The same holds true with Japan, Israel, and other counties where there are quite a few drug-producing companies.

Glufast, or mitiglinide calcium hydrate, is a diabetes medication from Japan, that has been in use there since 2004. It improves the body's own ability to produce insulin, and has the tendency to lower post-meal glucose levels in its users. However, it is not on the market in the United States. It is not even yet being considered by the FDA for approval. The company that owns the rights to market Glufast in North America, Elixir Pharmaceuticals, Inc., plans to submit a new drug application with the FDA in 2008. This is the way it goes in the global health care system.