The US Food and Drug Administration has recently approved the first generic Strattera for the treatment of ADHD. Strattera is a brand-name drug also known as Atomoxetine and it is used for managing ADHD (Attention deficit hyperactivity disorder) in adults and children.
What is ADHD?
ADHD is a brain disorder that is generally marked with an ongoing pattern of hyperactivity and inattention that affects proper development and functioning. The symptoms of Attention deficit hyperactivity disorder in about 80% of children may persist into puberty and it also has a probability of continuing into adulthood. Common warning signs of ADHD include impulsivity, hyperactivity, and inattention.
What are Generic Prescription Drugs?
Generic prescription drugs are identical to brand-name drugs in terms of characteristics such as performance, quality, strength, safety, and dosage form. Chemically, these drugs are similar to brand-name drugs but they are usually sold under discounts e.g. Strattera coupon, etc. Apart from this, generic prescription drugs also pass through the same quality standards as their brand-name alternatives.
Atomoxetine drug is prescribed for managing ADHD to decrease hyperactivity and impulsiveness and increase attention in children and adults. It falls under the category of medications known as selective norepinephrine reuptake inhibitors. Atomoxetine drug mainly acts by increasing norepinephrine levels. Norepinephrine is a natural chemical in the brain that is primarily responsible for controlling behavior. This drug comes in the form of capsule. Atomoxetine drug does not cure ADHD but helps to reduce the symptoms of the condition.
Some common side effects of this drug include mood swings, tiredness, dizziness, nausea or vomiting, decreased appetite, upset stomach, etc. In adults, common side effects include sexual side effects, dry mouth, constipation, etc.
FDA Approval Overview
FDA recently approved first generic version of Atomoxetine or Strattera for managing ADHD. The drug is quite popular as it has constantly brought in over half a billion dollars in revenue for big pharmaceutical company Eli Lilly. After the approval of the first generic Strattera, the approval of several other generic versions quickly followed. The newly approved challengers are Glenmark Pharmaceuticals, Aurobindo Pharma, Teva Pharmaceuticals, and Apotex.
The news of the approval of generic Strattera, which is also sold at discounted price via Strattera coupon, follows hot on the heels of another first approval for Glenmark, for its generic Bystolic. This drug is sold by Allergan.
The director of the Office of Generic Drugs in the Food and Drug Administration center for Drug Evaluation and Research Kathleen Uhl stated that the approval of the first generic Strattera marks an important step forward in bringing patients additional treatments that have met the rigorous standards of FDA. Uhl further said that it is FDA’s top priority to quickly bring generic versions of brand-name drugs to market so that patients have more options to manage/treat their conditions.
Scott Gottlieb, the new commissioner of FDA, recently outlined his intention to facilitate market access for generic drugs, including an action plan for drug competition along with a list of all drugs that are currently off-patent with no existing generic competition.