New River Pharmaceuticals in Radford has given the Food and Drug Administration its application to launch its first product, a drug to treat children ages 6 to 12 who suffer from the taxing mental health syndrome known as attention-deficit hyperactivity disorder.

As corporate milestones go, there are few ones bigger for a startup drug company than shipping the first new drug application to the FDA. New River Pharmaceuticals, with just 34 employees, took that step Tuesday, according to a Wednesday announcement.

With the FDA's approval, a process that normally takes 10 or fewer months, the 8-year-old company would have permission to begin sales of a drug that analysts have said could generate millions in revenue. New River Pharmaceuticals will share the money with the English drug company Shire Pharmaceuticals Group, its development, manufacturing, sales and marketing partner. New River said last May that the 2004 market for drugs of this kind in the U.S. was $1.5 billion. The recent market leader was Shire's Adderall XR.

Drug products are regulated by the Rockville, Md.-based FDA Center for Drug Evaluation and Research, whose charge is to assure the safety and effectiveness of medicine available to the American public. By this stage, human testing is complete or nearly so. It is time for the FDA to assemble a team to check the company's work.

FDA spokesman Stephen King, asked for a description of the government's review process, released a PowerPoint presentation which said the FDA "scrutinizes everything about the drug -- from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured."

The FDA defines a drug as "any product that is to be used for the prevention, diagnosis, treatment, reduce severity, or cure of disease, and is intended to affect the structure or any function of the body," King's presentation said.

The filing was not a surprise. The company had predicted the step for about a year.

At one time, big-rig trucks carried the new-drug applications of would-be drug companies to the FDA's doorstep, dropping off cases of paperwork running into the hundreds of thousands of pages, King said.

"This is primarily the reason that the FDA began moving into an electronic submission format in 1999," King said. "As you can imagine, we are simply running out of warehouse space for all this paper."