New First of its Kind Generic Drug Approved for Treatment of ADHD

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By U.S. Food and Drug Administration, Special for  USDR

 

The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult  patients.

Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited today gained approval to market atomoxetine in multiple  strengths.

“Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the  FDA.”

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.

ADHD is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or  development.

In the clinical trials for atomoxetine in children and adolescents, the most common side effects reported were upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings. In the clinical trials in adults, the most common side effects reported were constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and problems passing  urine.

Atomoxetine must be dispensed with a patient Medication Guide that describes the drug’s uses and warnings. This medication has a boxed warning for the increased risk of suicidal ideation in children and adolescents. Patients taking this medication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Other important warnings include the risk of severe liver damage and potential for serious cardiovascular  events.

For more  information:
FDA First Generic Drug  Approvals

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco  products.

SOURCE U.S. Food and Drug  Administration

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