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.

SCHIZOPHRENIA DRUG NOW AVAILABLE AS A GENERIC

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

Drug that treats symptoms of schizophrenia available for first time as a generic 

Americans that suffer the symptoms of schizophrenia now have a new treatment option in generic form. The FDA has approved the first generic versions of Seroquel (quetiapine) tablets.

An anti-psychotic drug, quetiapine treats the symptoms of schizophrenia. Quetiapine is also used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children. However, quetiapine is not approved by the FDA for the treatment of behavioral problems in older adults with dementia.

Quetiapine is one of many popular drugs recently approved by the FDA in a generic form. Generic drugs provide safe and effective alternatives to brand name drugs, usually at a lower cost. This approval is an important step in the Agency’s efforts to increase the availability of generic medications.

Schizophrenia is a chronic, severe, and disabling brain disorder. The problem affects around one percent of Americans, according to the National Institute of Mental Health (NIMH). The NIMH, which is part of the National Institutes of Health (NIH), was established with a mission of transforming the understanding and treatment of mental illnesses through basic and clinical research. People with the disorder may hear voices other people don't hear. They may believe other people are reading their minds, controlling their thoughts, or plotting to harm them.

Schizophrenia affects both men and women equally. It usually begins in the teen years or young adulthood but may begin later in life. It tends to begin later in women, according to the NIH.

While treatment helps relieve many symptoms of schizophrenia, most people who have the disorder cope with symptoms throughout their lives. Many people with schizophrenia can lead rewarding and meaningful lives in their communities, according to NIMH.
Quetiapine works by helping to restore the balance of certain natural substances in the brain. The medication helps decrease hallucinations, improves concentration, and prevents or decreases severe mood swings.

It is expected that quetiapine tablets will be manufactured in several different strengths. 

LIXIPRO, BONIVA, PLAVIX, AVAPRO DRUGS WILL SOON BE IN GENERIC FORM

The following excerpt is from an FDA e-mail: 

Generic versions of several popular brand-name drugs are muscling their way onto the prescription shelves. Generic equivalents of Lexipro (escitalopram)used to treat depression and generalized anxiety disorder; Boniva (ibandronate) to prevent and treat osteoporosis; Plavix (clopidogrel) used to prevent strokes and heart attacks; and Avapro (irbesartan) used alone or in combination with other medications to treat high blood pressure, are appearing soon with others to follow.