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81 days at the FDA

From ceramic hips to insulin inhalant

From ceramic hips to insulin inhalant

November 30, 1999|By KRISTIN WILSON

Americans have lots of problems. And drug companies have lots of solutions.

Try sticking antidepressant medication on your skin, or breathe deeply for a dose of insulin.

These ideas sound revolutionary, but they are just a glimpse of recent pharmaceutical innovations. Still, they mean nothing without a stamp of approval by the U.S. Food and Drug Aministration.

Almost every day, the FDA takes action on new products that can make American lives better and pharmaceutical companies richer. In February, the FDA approved more than 50 drug products.

Some approvals are minor ? giving the OK to a new label or dosage strength ? but the FDA also is charged with greater responsibility ? approving products that can change how Americans are medicated.

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For example, millions of diabetic Americans inject themselves with approved insulin every day to control blood-sugar levels, but Pfizer Inc. set out to change that. The company has developed a new way to deliver insulin to the body without using needles. The company's new drug Exubera hopes to offer the first noninjection form of insulin prescribed in the U.S. With Exubera, patients can simply inhale insulin.

Before Pfizer can realize the financial rewards of its new product and before diabetes patients can switch to inhalable insulin, Exubera must be approved by the FDA.

Sucampo Pharmaceuticals, a drug company based in Bethesda, Md., just spent five years and involved 2,000 people in 18 research studies to develop Amitiza, a prescription constipation relief drug.

But, without the FDA stamp of approval, the company had nothing, explains Dr. Edwin Rivera, medical director for the company.

"The FDA approval is everything," he says. "Before the approval, the drug is not available. Now that the drug is approved, it can be prescribed."

To drug companies and medical product developers, "FDA-approved" means millions, even billions, of dollars as drugs and products are cleared for distribution to American consumers. But the government institution is equally as important as the public's protector against products that are either harmful or ineffective.

The FDA also puts out patient information sheets about products and issues health advisories. It must approve products for new labeling and new strengths as well as review post-approval trials.

The following are some actions the FDA has taken the past 90 days and how the approval of these drugs and products will affect consumers:

Approval date: Feb. 28 ? The first antidepressant patch

Somerset Pharmaceuticals' Emsam product was approved as the first skin patch for use in treating major depression. The once-a-day patch was developed as an alternative to oral depression medications containing monoamine oxidase inhibitors (antidepressants). Antidepressant medications usually require dietary restrictions because the medication can cause spikes in blood pressure when certain foods are eaten. The Emsam patch, in its lowest dose, does not require a modified diet, according to the FDA approval.

Approval date: Feb. 22 ? First generic version of Flonase

Before Feb. 22, pharmaceutical company GlaxoSmithKline was the only company producing an allergy symptom nasal spray using fluticasone propionate. The nasal spray is prescribed as an anti-inflammatory nasal spray that treats nasal symptoms of indoor and outdoor allergies. The spray, called Flonase, generates annual sales of about $1.2 billion.

Roxane Laboratories is hoping to get a piece of that market with its FDA-approved generic version of the spray, Fluticasone Propionate Nasal Spray.

GlaxoSmithKline has filed a lawsuit to block the FDA's approval of the generic drug, and courts have temporarily suspended Roxane Laboratories' right to market and ship their version of the spray. Courts will consider GlaxoSmithKline's lawsuit today on whether the FDA approval will stand and whether Flonase will have a generic competitor.

Approval date: Jan. 27 ? A new way to control diabetes

The first inhalable form of insulin to treat Type 1 and Type 2 diabetes is approved. Pfizer's Exubera product is the first insulin option in the U.S. that does not need to be injected. Using a special inhaler, diabetes patients breathe in insulin in a dry powder form.

"Exubera was found in clinical trials to be as effective as short-acting insulin injections, and to significantly improve blood-sugar control when added to diabetes pills," according to a written statement from Pfizer Inc.

The inhalable insulin is expected to be available to patients later this year.

Approval date: Dec. 16, 2005 ? A ceramic hip

Biomet Inc. received approval for its ceramic hip joint replacement system that is believed to be a longer-lasting replacement than traditional synthetic joints.

Hip replacements are traditionally made of metal and resin parts. But the resin, called polyethylene, can wear out in 10 to 20 years, explains Biomet spokesperson Barb Goslee. Metal on metal and now ceramic on ceramic parts are used as alternatives and are believed to last longer.

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