FDA approves expanded use of Saphris
WHITEHOUSE STATION, N.J. Merck’s supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.
Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.
Saphris initially was approved by the FDA last summer for the acute treatment of schizophrenia in adults and as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
“These FDA approvals demonstrate our active commitment to further understand how our medicines can be used to help physicians help their patients, and we look forward to discussing these new uses for Saphris with the mental health community,” said David Michelson, VP neuroscience clinical research at Merck.
Watson gets FDA approval for generic Yasmin
MORRISTOWN, N.J. The Food and Drug Administration has approved a generic oral contraceptive made by Watson Pharmaceuticals, the drug maker said Tuesday.
Watson announced the FDA’s approval of Zarah (drospirenone and ethinyl estradiol tablets) in the 3 mg/0.03 mg strength. The drug is a generic version of Bayer’s Yasmin.
Watson said it has started shipping the drug, though Bayer’s patent litigation suit against the company concerning the drug remains pending in the U.S. District Court for the Southern District of New York.
Yasmin and generic versions had sales of around $97 million during the 12 months ended in June, according to IMS Health.
H1N1 prompts increase in thorough hand-washing among Americans
MILWAUKEE Concerns about last year’s H1N1 virus have had an impact on Americans’ hand-washing habits, according to a national survey conducted by Bradley Corp.
In Bradley’s second Healthy Hand Washing survey, 50% of the 1,053 respondents said they "wash their hands more thoroughly or longer or more frequently" in public restrooms as a result of the H1N1 virus — that’s up from 45% in 2009 when the same question was asked.
According to the National Institute of Allergy and Infectious Diseases, adults average two to four colds a year, and children have about six to 10. In fact, the common cold is a leading cause of doctor visits and missed days from school and work.
Bradley’s Healthy Hand Washing survey was conducted online from July 7 to 15, 2010, and queried 1,053 American adults about their hand-washing habits in public restrooms. Participants were from around the country, ranged in age from 18 to 65 years and older, and the split between men and women was 46% and 54%, respectively.