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.
CHPA to Hoosier State: E-tracking will curb PSE sales
WASHINGTON The Consumer Healthcare Products Association is slated to testify Wednesday before an Indiana legislative committee on how the state can improve its policies for preventing the illegal diversion of pseudoephedrine.
The Indiana State Legislature’s Criminal Law and Sentencing Policy Study Committee will hear a range of policy options, from requiring a prescription for currently accessible medicines to implementing an electronic tracking system to block illegal sales of PSE.
“The residents of Indiana deserve a solution that will help fight the state’s meth problem, without placing additional burdens on individuals, families and the state,” stated Mandy Hagan, director of state government relations for CHPA. “Electronic tracking is the only system that blocks illegal PSE sales while maintaining consumer access to the safe and effective medications they rely on for colds and allergies.”
In Indiana, there currently is no mechanism in place to curb the practice of “smurfing,” when criminals move from store to store to purchase illegal amounts of PSE to be used in the production of meth.
E-tracking, which has been adopted by 12 states nationwide and is funded by members of CHPA, will afford local law enforcement officials an investigative tool to track and prevent meth production across state lines. The system also preserves Indianans’ over-the-counter access to the PSE medications.
According to a poll by David Binder Research, almost two-thirds of surveyed Indiana voters oppose making common cold and allergy medications containing PSE available by prescription only, and 82% agree that an Rx-only requirement would create an “unnecessary burden” for law-abiding citizens.
The Indiana State Retail Association also supports implementation of an electronic tracking system.
The survey, conducted from Jan. 14 to 24, involved 368 Indiana state residents ages 18 years or over, all of whom voted in the last election, and has a margin of error of +/-5.1%. The survey was sponsored by CHPA.
CVS to offer uninsured patients free flu shots
WOONSOCKET, R.I. CVS Caremark is partnering with nonprofit Direct Relief USA to offer up to $5 million in free flu shots to community clinic and health center patients who lack health insurance, the company announced on Wednesday.
Direct Relief USA works with 1,100 clinics and health centers in all 50 states, providing them with free medications and supplies for their low-income and uninsured patients. Most of the facilities in Direct Relief’s network are affiliated with either the National Association of Community Health Centers or the National Association of Free Clinics. CVS Caremark and Direct Relief USA will distribute vouchers redeemable for a free flu shot at any CVS/pharmacy or MinuteClinic to participating clinics and health centers. These facilities will identify uninsured individuals from their existing patient populations in order to provide them with a free flu shot voucher.
Beginning Sept. 20, CVS free flu shot vouchers for the uninsured will be available at participating community clinic and health centers for their existing patients. Names and locations of participating clinics will be made available on Sept. 20.
"With every CVS/pharmacy and MinuteClinic location providing flu vaccinations this year, we want to make sure that as many people as possible have access to a flu shot, including patients for whom cost may be a barrier," stated Larry Merlo, president and COO of CVS Caremark. "The Centers for Disease Control and Prevention is recommending that everyone receive a flu shot this year. We are pleased to partner with Direct Relief USA to help accomplish that goal."