Amylin Pharmaceuticals said yesterday that federal regulators have approved the use of its drug Symlin to treat diabetes, capping a drug development process that began almost 18 years ago.

Symlin represents the first new drug for the treatment of diabetes since insulin was introduced in the 1920s. It also is San Diego-based Amylin's first product to win clearance by the U.S. Food and Drug Administration.

The FDA's approval also comes at a time of increased scrutiny on the pharmaceutical industry, after government regulators ordered at least two drugs withdrawn out of concern over dangerous side effects.

Amylin's new drug is a synthesized version of amylin, a naturally occurring hormone that is produced by the same cells in the pancreas that make insulin.

Symlin is to be used in conjunction with insulin to help diabetes patients better manage their blood sugar levels.

"The addition of Symlin helps them in several ways," said Ginger Graham, Amylin's chief executive. "It allows them to reduce their overall insulin dose.

It helps them get better control of their blood sugar, particularly after a meal. And for those who are overweight, it helps them control their weight."

The drug should be available to the public within 90 days, the company said.

Amylin experienced a number of setbacks in its protracted quest to develop a new diabetes drug, which included clinical trials involving more than 5,300 people. The process required the company to raise $1.3 billion, Graham said.

Symlin may have peak sales of $300 million a year, said analyst Buddy Lyons of the Stanford Group in Memphis, Tenn. He does not expect Symlin to develop a broad market, in part because it requires three injections a day.

Lyons and other analysts hold greater expectations, though, for exenatide, another diabetes drug being developed by Amylin. The FDA is expected to issue its ruling by April 30 for exenatide, which Lyons said has the potential to become a $1 billion a year drug.

Roughly 18.2 million Americans, or 6.3 percent of the U.S. population, have diabetes, according to the American Diabetes Association. It is the nation's fifth leading cause of death by disease.

The ADA describes diabetes as a group of diseases characterized by high levels of blood sugar caused by the body's inability to produce insulin, a hormone, or by defects in the action insulin has on blood sugar.

Amylin was founded in 1987, after scientists at the University of Oxford discovered that the pancreatic cells that produce insulin also manufacture a previously unknown hormone, which they called amylin. Their research established that insulin does not act alone to metabolize sugars.

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