FDA, CDC reiterate safety of HPV vaccine
ATLANTA Based on ongoing assessments of vaccine safety information, the Food and Drug Administration and the Centers for Disease Control and Prevention continue to find that the human papillomavirus vaccine Gardasil is a safe and effective vaccine, the two agencies stated jointly last week.
Studies involving approximately 21,000 girls and women were conducted to evaluate the safety and effectiveness of Gardasil before receiving approval by FDA. These studies showed that in women who have never been infected by HPV types 6, 11, 16 or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina and vulva, and in preventing genital warts caused by these HPV types.
FDA approved Gardasil June 8, 2006 for females between the ages of 9 and 26 to protect against cervical, vulvar and vaginal cancers caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11. CDC’s Advisory Committee on Immunization Practices recommended a routine 3-dose vaccination series for girls 11 and 12 years of age. The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or who have not received all 3 doses.
FDA and CDC continue to monitor the safety of this vaccine, with the public’s health and safety our top priority.
Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.
FDA approves Ranbaxy’s generic peptic ulcer treatment
PRINCETON, N.J. The Food and Drug Administration has given an India-based drug maker final approval to market a generic drug for treating peptic ulcer.
Ranbaxy Pharmaceuticals, a U.S. subsidiary of Ranbaxy Labs, announced Monday the approval of glycopyrrolate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Sciele Pharma’s Robinul and Robinul Forte tablets, respectively.
“We are pleased to receive this final approval for glycopyrrolate tablets,” Ranbaxy Pharmaceuticals VP sales and distribution Jim Meehan said in a statement.
Meehan said the drug would be launched between October and December. Glycopyrrolate tablets had sales of $26 million during the 12-month period ending in June, according to IMS Health data.
Supervalu EVP joins NACDS board of directors
ALEXANDRIA, Va. An organization catering to the retail pharmacy industry has elected a new member to its board.
The National Association of Chain Drug Stores announced that Duncan Mac Naughton, EVP merchandising and marketing for Supervalu, was elected to the board of directors, effective Aug. 14. Mac Naughton will fill the position vacated by Kevin Tripp, who recently retired as Supervalu’s EVP of its retail Midwest division.
Mac Naughton will serve the remainder of the 2009-2010 term until April 2010, when the annual board of directors elections are held at the NACDS Annual Meeting.
Mac Naughton has a career of service within the supermarket industry. He has served on SUPERVALU’s executive team since joining the company in 2006 upon its acquisition of Albertsons, where Mac Naughton had served as executive vice president of merchandising. Prior to Albertsons, he served in key leadership roles at H-E-B and Kraft Foods.
“We are pleased to welcome Duncan to the NACDS Board of Directors,” said NACDS president and CEO Steve Anderson. “NACDS’ diverse membership is well-represented by the NACDS Board of Directors. Duncan brings leadership and expertise on behalf of the supermarket segment, and we look forward to working together to advance pharmacy as the face of neighborhood healthcare and to add value to NACDS’ engagement in front-end activities.”