Actavis seeks approval for generic acne drug
DUBLIN — Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.
The drug maker announced that it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Acanya (clindamycin phosphate; benzoyl peroxide) gel in the 1.2%/2.5% strength. Acanya is made by Valeant Pharmaceuticals International and Dow Pharmaceutical Sciences and is used to treat acne vulgaris in patients aged 12 and older.
The filing contained a paragraph IV certification, a legal challenge to a patent on the drug, triggering a lawsuit against Actavis that Dow and Valeant filed in the U.S. District Court for the District of New Jersey last week. Under the Hatch-Waxman Act of 1984, the lawsuit places a 30-month stay of FDA approval on Actavis’ product, unless the companies settle the case. As the first company to successfully file for FDA approval, Actavis would be entitled to 180 days of market exclusivity in which to market the direct in direct competition against the branded version.
Acanya had sales of $62 million during the 12-month period that ended in July, according to IMS Health.
FDA introduces e-learning program about untruthful, misleading drug ads
SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.
The FDA’s Office of Prescription Drug Promotion announced Monday the launch, with MedScape, of the e-learning course, which offers continuing education credits for healthcare professionals. The course is part of Bad Ad, a program designed in 2010 to raise awareness about misleading and untruthful drug ads. It’s aimed at healthcare professionals, but anyone can take it, the agency said. The office has developed several case studies based on warning letters the FDA has sent to drug companies, representing common problems.
"We encourage medical, pharmacy, nursing and other healthcare-related schools to incorporate these cases into their coursework," Office of Prescription Drug Promotion director Thomas Abrams wrote in a blog entry on the FDA’s website. "The cases cover a range of promotional materials including a website, journal ad and TV ad, and touch upon numerous promotional practices that don’t comply with our regulations."
Walgreens collects donations for Susan G. Komen
DALLAS — Walgreens is collecting donations for breast cancer treatment through a partnership with Susan G. Komen to mark National Breast Cancer Awareness Month, which takes place this month.
The retail pharmacy chain and its customers raised more than $8.5 million last year to support community health and education programs, and Komen and affiliates were able to provide funding for more than 15,000 mammograms to uninsured and underinsured people and for education and patient navigation services to another 222,000, as well as for expansion of its national breast care helpline.
"We were so delighted with the outpouring of support from Walgreens and Walgreens customers last year," Susan G. Komen chief mission officer Chandini Portteus said. "These funds are making a significant impact in communities across the country, providing access to screening mammograms, treatment assistance and other services that otherwise would go unfunded."
For the donation drive, Walgreens is collecting money at its more than 8,000 stores through Thursday.