- 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
is a brain disorder that is usually marked with an ongoing
pattern of inattention and hyperactivity that affects proper functioning and
What are Generic
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
generics to market so patients have more options to treat their conditions is a
top priority for the FDA", added Uhl.
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
Some of the most common side effects that
were reported in children and adolescents include:
- Upset stomach
- Nausea or
- Mood swings
Common side effects in
- Dry Mouth
- Reduced appetite
- Sexual side
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
- Atomoxetine - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561096.htm)
- Attention Deficit Hyperactivity Disorder - (https://www.cdc.gov/ncbddd/adhd/facts.html)
- FDA approves first generic Strattera for the treatment of ADHD - (https://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml)
- Facts About ADHD - (https://medlineplus.gov/druginfo/meds/a603013.html#why)