PHARMACY

Mylan set to ship acne treatment

BY Alaric DeArment

PITTSBURGH A U.S. generic drug maker has released the first generic version of an acne medication.

Mylan announced Thursday that it had started marketing its 1% clindamycin and 5% benzoyl peroxide gel, through an licensing agreement with Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International. The gel is a generic version of Sanofi-Aventis’ BenzaClin.

The Food and Drug Administration gave Dow approval for the generic version on Aug. 11. Under the Hatch-Waxman Act of 1984, Mylan’s version of the drug has six months to compete directly with the branded version, which had sales of $221 million for the 12 months ending June 30, according to IMS Health data.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

FDA allows DoD to distribute swine flu test to soldiers

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration will allow the Department of Defense to distribute a test for detecting the swine flu in soldiers serving overseas.

The FDA announced Tuesday that it had issued an emergency use authorization for the test, developed by the Centers for Disease Control and Prevention and called the CDC swH1N1 Influenza Real-Time RT-PCR. An EUA allows the use of unapproved medical products or unapproved uses of them during a declared public health emergency. The 2009 H1N1 influenza virus was declared a global pandemic this summer, making it the first influenza pandemic since 1968.

“The FDA worked quickly with the Defense Department to authorize the use of this test to better protect our troops,” FDA commissioner Margaret Hamburg said in a statement. “The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Study finds leukotriene modifiers work best for asthma sufferers

BY Alaric DeArment

WILMINGTON, Del. Asthma patients have an easier time controlling their disease with oral controllers than with a common type of inhaled drug, according to a new study.

In a peer-reviewed study requested by WellPoint, conducted by HealthCore and published in Mayo Clinic Proceedings, patients taking oral controllers called leukotriene modifiers had better clinical results than those taking inhaled corticosteroids.

“Clinical superiority of the inhaled products has been well-documented in clinical trials, and the HealthCore study confirmed this for those who take their medication properly,” HealthCore VP clinical affairs Joseph Singer said in a statement. “However, we were surprised to discover that in looking at all patients in real-world settings, oral controllers appeared to be a better choice of treatment because of better compliance.”

Common leukotriene modifier brands include Merck & Co.’s Singulair (montelukast sodium), AstraZeneca’s Accolate (zafilukast) and Cornerstone Therapeutics’ Zyflo (zileuton).

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?