Urged by CDC, FDA issues Emergency Use Authorizations for antiviral products
ROCKVILLE, Md. The Food and Drug Administration, in response to requests from the Centers for Disease Control and Prevention, on Monday issued Emergency Use Authorizations to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances.
The agency issued these EUAs for the use of GlaxoSmithKline’s Relenza (zanamivir) and Roche’s Tamiflu (oseltamivir phosphate) antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.
The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.
Currently, Relenza is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older. Tamiflu is approved for the treatment and prevention of influenza in patients 1 year and older.
The EUAs allow for Tamiflu also to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year. In addition, under the EUAs, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.
In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic test, the FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests. This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results.
The test amplifies the viral genetic material from a nasal or nasopharyngeal swab. A positive result indicates that the patient is presumptively infected with swine flu virus but not the stage of infection. However, a negative result does not, by itself, exclude the possibility of swine flu virus infection.
The EUA authority is part of Project BioShield, which became law in July 2004.
FDA, SAMHSA to develop education campaign for methadone
ROCKVILLE, Md. A drug used to treat pain and heroin addiction is one of the most-abused prescription drugs in the country, but two government agencies will collaborate to educate the public on how to use it safety.
The Food and Drug Administration and the Substance Abuse and Mental Health Services Administration announced Monday that they would launch a joint education campaign within SAMHSA about the safe use of methadone.
The agencies will hold a press conference Tuesday morning to mark the launch of the program.
Decision Resources releases bipolar depression report
WALTHAM, Mass. Psychiatrists treating patients with bipolar depression base their prescribing decisions on a therapy’s effect on decrease in severity of depressive symptoms, a report released Monday has found.
Decision Resources’ report, “Bipolar Depression: Despite Negative Results, Physicians Still Hopeful About Aripiprazole,” based on a survey of psychiatrists in the United States and Europe, also found that an orally administered drug that carries a lower risk of weight gain than AstraZeneca’s Seroquel (quetiapine fumarate) would earn a 21% patient share in bipolar depression in the United States and a 30% share in Europe.
Most of the people interviewed also thought that Abilify (aripiprazole), made by Bristol-Myers Squibb and Otsuka Pharmaceutical, is an efficacious therapy for bipolar depression despite its failure in clinical trials of people with the disorder.