PHARMACY

Lev submits complete response letter to FDA for Cinryze

BY Diana Alickaj

NEW YORK In response to the Food and Drug Administrations issuance of a complete response letter, Lev Pharmaceuticals announced that it has formally submitted the form for Cinryze, a treatment used for acute and prophylactic treatment of hereditary angioedema.

According to published reports, the complete response letter issued by the FDA requested more information about the chemistry, manufacturing and controls of the treatment, as well as any additional data from the Cinryze clinical trials.

The focus for Lev is to obtain market approval for the treatment by the FDA and is scheduled to present to the Blood Products Advisory Committee on May 2, 2008, to educate and provide more information about the product.

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PHARMACY

FDA approves Alcon’s Patanase for nasal allergy symptoms

BY Adam Kraemer

HUENENBERG, Switzerland Alcon announced that the Food and Drug Administration has approved Patanase (olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

“We look forward to providing doctors the opportunity to prescribe Patanase to their patients who need and want a fast-acting nasal spray that quickly relieves symptoms,” said Kevin Buehler, Alcon’s senior vice president of global markets and chief marketing officer. “We are excited to enter the nasal market and are confident that this new addition will continue to grow our topical allergy franchise.”

Clinical studies found that patients treated with Patanase, two sprays per nostril, twice daily, demonstrated significantly greater decreases in symptoms compared to the placebo nasal spray. Additionally, onset of action was evaluated in three studies, in which patients with seasonal allergic rhinitis were exposed to high levels of pollen and then treated with either Patanase or placebo nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly for the subsequent 12 hours. Patanase nasal spray was found to have an onset of action of 30 minutes and a 12-hour duration of affect after dosing, which was statistically significant compared to the placebo spray.

“For patients who suffer every allergy season with symptoms that make life in those months miserable, Patanase offers relief beginning in minutes in a convenient steroid-free nasal spray,” said one study’s lead investigator, Eli Meltzer. “The fact that it works quickly is important. Patients in our fast-paced society want rapid improvement and relief from their nasal allergies.”

Patanase nasal spray, an extension to Alcon’s market-leading ocular allergy product line, will be available in May of this year.

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EPA sets up collection sites in eight states for used meds

BY Adam Kraemer

BUFFALO, N.Y. The Environmental Protection Agency, recognizing that trace amounts of pharmaceuticals are showing up in drinking water, has begun urging consumers living near any of the Great Lakes to bring their old medications to official collection centers.

The EPA is helping pay for more than 70 collection points in eight states that will take old medicine—along with electronic waste like computers, cell phones and televisions—from April 19 through April 27. The agency has set a goal of collecting 1 million pills during an Earth Day initiative aimed at the more than 30 million people who live around the Great Lakes, which are by far the largest source of fresh drinking water on the planet.

The collection sites are being established in New York, Illinois, Indiana, Michigan, Minnesota, Ohio, Pennsylvania and Wisconsin.

“We’re trying to raise public awareness on disposing of pharmaceuticals properly and we’ve had a very good response from communities on water districts. This is information that needs to get out there,” EPA spokeswoman Phillippa Cannon said Tuesday.

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