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Last Updated: Mar 16, 2012 04:10PM • Subscribe via RSSATOM

FDA Approves Generic Lexapro to Treat Depression and Anxiety

The U.S. Food and Drug Administration today approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults. 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 major 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. People with generalized anxiety disorder (GAD) are filled with exaggerated worry and tension, even though there is little or nothing to provoke it. They anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work. GAD is diagnosed when a person worries excessively about a variety of everyday problems for at least six months. People with GAD can’t relax, startle easily, and have difficulty concentrating. “These psychiatric conditions can be disabling and prevent a person from doing every-day activities,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options.” Teva Pharmaceutical Industries/IVAX Pharmaceuticals gained FDA approval to market generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths. In the clinical trials for Lexapro, the most commonly observed adverse reactions were: sleeplessness (insomnia), ejaculation disorder, nausea, increase in sweating, fatigue and drowsiness, and low sex drive (decreased libido). Escitalopram and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment. The warning also says data did 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. Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA cannot approve another generic version of escitalopram tablets before the end of that period. Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs. Information about the availability of generic escitalopram can be obtained from Teva.

Living Life Unplugged

We’ve heard lots about the distractions caused by cell phone use and texting while we drive.

Breakfast, The French Call it “Little Lunch”

You have heard it time and again: Breakfast is the most important meal of the day.

There's Snow Somewhere: Kite-skating

Although it's been a balmy 60 degrees here in Annapolis, the temperatures in St. Ignace, Michigan have been below freezing. That's the perfect temp for the Upper Peninsula town to host the 2012 World Ice and Snow Sailing Association, an annual gathering of cold weather enthusiasts who don't think the relative chance of hypothermia should inhibit them from going sailing. And while ice boating has been all the rage lately, we wanted to bring some attention to a new form of getting out on the water: kite-skating. While the combination of ice skating and kitesurfing may seem like a no-brainer, they're two of the most technically difficult sports to master. We give those Yoopers and the World Ice and Snow Sailing Association huge props.

FDA Announces Changes for Cholesterol Drugs

 Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.

No Need to Feel SAD

When the weather gets colder and the days get shorter, do you feel yourself getting a chronic case of the blues?

On the Other Hand: What's so special about being left-handed?

What's so special about being left-handed?

Leap into Heart Health

February is American Heart Month, thanks to St. Valentine and the American Heart Association.

We've Got Your Back

Each year, one in four Americans experience lower back pain.

Multi-tasking Taken Too Far?

Exercising as you work, this may be going too far.