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.
Greenstone, Eisai to launch authorized generic of Aricept
PEAPACK, N.J. The generics division of Pfizer will sell an authorized generic version of a drug used to treat dementia.
Greenstone said Wednesday that it had agreed with Eisai to launch donepezil hydrochloride tablets, an authorized generic of Aricept. The drug is used to treat dementia related to Alzheimer’s disease. Eisai makes the drug under a partnership with Pfizer.
“We are excited about the opportunity to work with Eisai to introduce this important authorized generic to patients,” said James Cannon, Greenstone’s VP business alliances. “First and foremost, our goal is to provide donepezil hydrochloride tablets to the broad customer base, and we also strive to remain competitive with other potential generic versions of the product.”
Unlike generic drugs, which are marketed in competition with their branded counterparts and must undergo an abbreviated regulatory approval process through the Food and Drug Administration, authorized generics are essentially branded drugs marketed under their generic names with the authorization of the original drug’s manufacturer and often through third-party companies.