FDA advisory committee recommends expanded use of Gardasil
WHITEHOUSE STATION, N.J. — A Food and Drug Administration advisory committee has recommended expanded approval of a vaccine for genital warts.
Merck announced Wednesday that the FDA Vaccines and Related Biological Products Advisory Committee recommended approval of Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for males and females ages 9 to 26 years to prevent anal cancer and anal intraepithelial neoplasia, both diseases that result from infection by the human papillomavirus.
Merck’s application was based on a clinical study of Gardasil in men who have sex with men, for whom anal infection by HPV is a high risk, though it submitted its application for men and women because the disease affects and is similar in both genders.
Takeda launches GetToKnowGERD.com
NEW YORK — Drug maker Takeda Pharmaceuticals is launching a campaign to raise awareness of gastroesophageal reflux disease, the company said Tuesday.
Takeda created the website GetToKnowGERD.com to coincide with GERD Awareness Week, which takes place from Nov. 21 to 27. The company also is using the occasion to promote the GERD drug Dexilant (dexlansoprazole).
GERD is an often chronic condition characterized by frequent heartburn that affects nearly 19 million Americans, but according to an Omnibus telephone poll of 1,000 U.S. adults conducted in October, around 80% of people are not aware of how common it is.
Labopharm reviewing notification of Actavis’ approval application for generic Oletpro
LAVAL, Quebec — Generic drug maker Actavis has filed for approval of a generic version of an antidepressant made by Canada’s Labopharm, Labopharm said.
The drug maker said it received a notification stating that Actavis had applied to the Food and Drug Administration for approval of a generic version of Oletpro (trazodone hydrochloride) extended-release tablets in the 150-mg and 300-mg strengths.
Actavis’ application contained a Paragraph IV certification, a legal challenge to a Labopharm patent covering the drug, which expires in June 2020. The market exclusivity period, which prevents the FDA from approving Actavis’ version, expires in February 2013.
Labopharm said it was reviewing the letter to determine what steps to take, though under the Hatch-Waxman Act of 1984, it is allowed to file a lawsuit against Actavis to prevent the latter from marketing its generic version of the drug.