FDA Approves Generic Drug Atomoxetine to Treat Attention Deficit Hyperactivity Disorder (ADHD)

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Highlights:

• Attention deficit hyperactivity disorder (ADHD) is a brain disorder marked with an ongoing pattern of inattention or hyperactivity.
• The United States Food and Drug Administration (FDA) has now approved the generic version of atomoxetine drug for ADHD.
• Atomoxetine drug increases attention and decreases impulsiveness and hyperactivity in children and adults.

The United States Food and Drug Administration has recently approved the first generic version of Atomoxetine (Strattera) drug for the treatment of ADHD (Attention deficit hyperactivity disorder) in children and adults.

Attention deficit hyperactivity disorder is a brain disorder that is usually marked with an ongoing pattern of inattention and hyperactivity that affects proper functioning and development.

What are Generic Prescription Drugs?

Generic drugs are identical to brand name drugs in terms of dosage form, safety, strength, quality and performance characteristics. The drugs are chemically similar but sold under discounts when compared to brand name drugs.

‘The FDA approves generic version of Atomoxetine drug for the treatment of ADHD.’

The generic prescription drugs are also required to pass through the same quality standards as that of the brand-name drugs.

Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said, "Today's approvals mark an important step forward in bringing consumers additional treatments that have met the FDA's rigorous standards."

"Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA", added Uhl.

Atomoxetine Drug

Atomoxetine drug is prescribed for ADHD treatment to increase attention and decrease impulsiveness and hyperactivity in children and adults. It belongs to a group of medications called selective norepinephrine reuptake inhibitors.

The drug mainly acts by increasing the levels of norepinephrine which is a natural substance in the brain that is required to control behavior.

Atomoxetine comes in the form of a capsule to take by mouth. It helps to reduce the symptoms of ADHD but however, will not cure the condition.

Side Effects of Atomoxetine

Some of the most common side effects that were reported in children and adolescents include:

• Upset stomach
• Decreased appetite
• Nausea or vomiting
• Dizziness
• Tiredness
• Mood swings

Common side effects in adults include:

• Constipation
• Dry Mouth
• Nausea
• Reduced appetite
• Dizziness
• Sexual side effects

Boxed Warning

The drug may increase the risk of suicidal ideation. Therefore, patients taking the drug should be monitored closely for unusual changes in the behavior.

Other warnings may include severe liver damage and serious heart events.

The generic drug has been approved by the FDA to Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited for marketing atomoxetine in different strengths.

What is ADHD?

It is one of the most common neuro-developmental disorders in childhood. Brain injury, alcohol and tobacco use during pregnancy, premature delivery and low birth weight are some of the causes and risk factors for ADHD. Around 1 in 20 children in the United States is affected by ADHD.

The symptoms of ADHD in about 80% of children may persist into adolescence and continue into adulthood.

Three Warning Signs of ADHD

• Inattention
• Hyperactivity
• Impulsivity

References:

1. Atomoxetine - (https:www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561096.htm)
2. Attention Deficit Hyperactivity Disorder - (https:www.cdc.gov/ncbddd/adhd/facts.html)
3. FDA approves first generic Strattera for the treatment of ADHD - (https:www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml)
4. Facts About ADHD - (https:medlineplus.gov/druginfo/meds/a603013.html#why)

Source: Medindia

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