Menactra approved for use in infants, toddlers
SILVER SPRING, Md. — The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.
The FDA announced the approval of Menactra, made by Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis. Meningococcal disease is a life-threatening illness caused by Neisseria meningitidis bacteria that infect the bloodstream and the lining surrounding the brain and spinal cord.
Between 10% and 15% of people who develop meningococcal disease die from the infection, even with appropriate antibiotics and intensive care, while another 10% to 20% suffer such complications as brain damage, loss of limbs and hearing loss.
Menactra already had FDA approval for patients ages 2 to 55 years.
Walgreens collects more than 15,000 lbs. of unused, expired medications
HOUSTON — Walgreens’ Safe Medication Disposal Program, launched in September 2010 in partnership with Sharps Compliance, has collected more than 15,000 lbs. of unused or expired medications, Walgreens announced Monday.
“We estimate that more than 200 million lbs. of unused dispensed medications are disposed of improperly each year,” Sharps Compliance president and CEO David Tusa said.
“We are encouraged that many of our patients have taken advantage of this medication disposal opportunity,” stated Richard Ashworth, Walgreens VP pharmacy operations. “In addition to the environmental benefits, it addresses a common safety concern in communities. Customers are pleased to have a solution that allows them to be environmentally responsible and keep medications out of unintended hands with convenience and ease.”
As part of the program, U.S. Postal Service-approved envelopes are available at Walgreens for $3.99 for customers to place, seal and mail prescription or over-the-counter medications they no longer use to a facility for proper treatment. Controlled substances are excluded from this program due to current regulations. Postage is included in the cost of the envelope.
Pozen, AstraZeneca file suit against Dr. Reddy’s over generic Vimovo
CHAPEL HILL, N.C. — A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.
Pozen and AstraZeneca on Monday said that they have filed the suit in the U.S. District Court for the District of New Jersey against Dr. Reddy’s. The drug makers said Dr. Reddy’s is seeking approval from the Food and Drug Administration for its generic version of Vimovo (naproxen/esomeprazole magnesium) delayed-release tablets prior to the patent’s expiration date. Vimovo currently has regulatory exclusivity through April 30, 2013, Pozen and AstraZeneca said.
The filing of this patent infringement lawsuit by AstraZeneca and Pozen within 45 days of receipt of Dr. Reddy’s notice letter will result in the FDA automatically instituting a stay or bar of final approval of Dr. Reddy’s abbreviated new drug application for up to 30 months, or until a final court decision is entered in the infringement suit in favor of Dr. Reddy’s, whichever occurs first.