FDA GIVES APPROVAL FOR GENERIC VERSIONS OF CYMBALTA

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
FDA NEWS RELEASE
 For Immediate Release: Dec. 11, 2013
FDA approves first generic versions of antidepressant drug Cymbalta

The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.

Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. have received FDA approval to market duloxetine in various strengths.

“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs offer greater access to health care for many people.”

Depression is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime. Signs and symptoms of depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide.

Duloxetine and other antidepressant drugs have a boxed warning describing the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults ages 18 to 24. The warning also says data do not show this increased risk in those older than 24 years and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior.

The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary. Duloxetine must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks.

Common adverse reactions reported by people taking Cymbalta include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic duloxetine can be obtained from the manufacturers.

CDC RECOMMENDS THOSE BORN BETWEEN 1945-1965 BE TESTED FOR HEPATITIS C

FROM: CENTERS FOR DISEASE CONTROL
New CDC Vital Signs: Hepatitis C Testing

A new multi-area study suggests that only half of Americans with hepatitis C receive complete testing for the virus.
Approximately three million Americans are living with hepatitis C and up to 75 percent don’t know they are infected – placing them at serious risk for liver disease, cancer, and death.

Only half of Americans identified as ever having had hepatitis C received follow-up testing showing that they were still infected, according to an analysis of data from a multi-area study published today. This data suggest that even among individuals who receive an initial antibody test, as many as half do not know for sure if they still carry the virus.

The vast majority of persons living with hepatitis C are baby boomers (individuals born from 1945 through 1965). In fact, the snapshot of diagnosed hepatitis C cases and deaths provided by this analysis underscores the severe impact among this population.

CDC is issuing updated guidance to reinforce current recommendations for hepatitis C testing and to ensure people infected with hepatitis C are properly tested and identified. Testing all baby boomers properly is critical to stem the increasing toll of death and disease from hepatitis C in this nation.
CDC recommends that everyone in the U.S. born from 1945 through 1965 be tested for hepatitis C in order to increase the proportion of those who know they are infected and linked to care. CDC also recommends that other populations at increased risk for hepatitis C get tested.