Lexapro indication








Forest39s Lexapro receives FDA non-approval letter for expanded

12/18/2014
04:32 | Author: Jeremy Rodriguez

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Forest39s Lexapro receives FDA non-approval letter for expanded

Lexapro is currently approved in the US for the initial and maintenance treatment of major depressive disorder and for generalised anxiety.

The drug had sales of $427 million in the three months ended December 31, TheStreet reports. In Europe, it is approved to treat depression, social anxiety disorder and panic disorder. Lexapro is currently approved in the US for the initial and maintenance treatment of major depressive disorder and for generalised anxiety disorder in adults.

The FDA on Wednesday issued a non-approval letter for Forest's antidepressant, Lexapro, as a treatment for social anxiety disorder, Forbes and other news sources report.

Once data from one study centre was eliminated, the results failed to achieve statistical significance. Forest noted that in the non-approvable letter, the FDA said that data from one of two trials supported the application, but the agency also "raised questions related to the reliability of patient data at one study centre in the second study," TheStreet reports.

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The drugmaker said it is reviewing the agency's analysis "and will determine the appropriate next steps. in the coming months," TheStreet reports. The FDA's rejection for this indication is the second in four weeks, after it denied Forest's application to market the drug as a treatment for panic disorder.

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Lexapro(TM) Receives FDA Approval for the Treatment of - Investors

12/18/2014
02:04 | Author: Chloe Allen

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Lexapro(TM) Receives FDA Approval for the Treatment of - Investors

impacts an individual's daily functioning. Lexapro is also indicated for the initial treatment and maintenance of major depressive disorder.

The new indication is based on three studies, all of which were positive and support the efficacy and safety of Lexapro in the treatment of GAD. Food and Drug Administration (FDA) has approved Lexapro(TM) (escitalopram oxalate), a selective serotonin reuptake inhibitor (SSRI), for the treatment of generalized anxiety disorder (GAD), a condition that affects approximay four million Americans annually.

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Lexapro Wins FDA Approval for Adolescent Depression Indication

12/18/2014
12:44 | Author: Allison King

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Lexapro Wins FDA Approval for Adolescent Depression Indication

The FDA expanded the indication for Forest Laboratories' antidepressant Lexapro to acute and maintenance treatment of major depressive disorder in.

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1 Receives Non Approvable Letter For Panic Disorder Indication For

12/18/2014
02:12 | Author: Chloe Allen

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1 Receives Non Approvable Letter For Panic Disorder Indication For

Lexapro is indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults.

Triano, Vice President - Investor Relations ofForest Laboratories, Inc., +, Web site: http://www.frx.com/. CONTACT: Charles E.

BioSpace is a Dice Holdings, Inc., Company.

NEW YORK, March 1 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, today reported that the U.S. Lexapro is indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults. Both studies included in the submission have been previously published in medical journals. Food and Drug Administration (FDA) has issued a second non-approvable letter for the indication of Panic Disorder for Lexapro(R) (escitalopram oxalate), an SSRI antidepressant. The Company is currently reviewing the FDA's response in order to determine the appropriate action regarding the Panic Disorder submission. The Company indicated that the letter was pursuant to an FDA review of its response, dated August 2004, to an initial non-approvable letter which raised issues related to methods and statistical analyses performed for the two placebo-controlled trials provided in the submission. (Logo: http://www.newscom.com/cgi-bin/prnh/ /FORESTLOGO ).

These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q for the periods ended June 30, 2004, September 30, 2004 and December 31, 2004. Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/ /FORESTLOGO. Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those projected.

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Antidepressants Comparison of SSRIs

12/18/2014
04:00 | Author: Jeremy Rodriguez

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Antidepressants Comparison of SSRIs

Celexa (Citalopram) licensed indications: depression. Lexapro (Escitalopram) licensed indications: major depressive disorder; generalized.

All SSRIs (except paroxetine) are classified as pregnancy Category C, meaning that they may not be safe for use during pregnancy.

It is the active isomer of racemic citalopram. Lexapro (Escitalopram oxalate) is the newest and most selective of the SSRIs approved by the FDA in August 14, 2002. Lexapro is a cleaner, improved version of Celexa. Lexapro is manufactured by Forest Pharmaceuticals, Inc.

Dry mouth Citalopram and paroxetine are more likely to cause dry mouth than escitalopram and fluoxetine.

Paroxetine may cause heart defects or serious, life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy.

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