FDA approves Actavis' generic ADHD drug
  • Tue, 06/26/2012 - 3:34pm

The U.S. Food and Drug Administration recently created competition for Adderall XR manufacturer Shire PLC by approving another company’s generic form of the ADHD medication.
Adderall XR, which contains stimulants amphetamine and dextroamphentamine, treats attention deficit hyperactivity disorder (ADHD) by increasing the activity of specific brain chemicals, including dopamine and norepinephrine.
Previously, only two generic forms of Adderall existed and both were owned by Shire, according to the Huffington Post. The new generic drug offers consumers a less expensive alternative.
According to MedicineNet writer Melissa Stoppler, generic drugs are chemically identical to brand name drugs and held to the same FDA standards as brand name drugs.
Further, she writes, “Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.”
Actavis, which will soon become part of Watson Pharmaceuticals, did not expect its generic drug to be approved until at least 2013. Although Adderall XR’s patent expired in 2009, production of generic versions has been delayed due to  the drug’s complexity and a petition Shire PLC issued for stricter tests of generic versions.
Companies apply for patents for sole possession of a product for a set period of time, according to MedicineNet. Once a drug is patented, its chemical formulation belongs to the company that manufactured it.
In addition to ADHD medications Vyvanse, Intuniv and Adderall XR, Shire PLC recently delved into developing drugs to treat rare diseases like Fabry disease, Hereditary Angioedema, Hunter syndrome, and Gaucher disease.
According to MedicineNet, ADHD is a life-long behavioral disorder that effects 8 to 10 percent of children in the U.S. Characteristics of ADHD include:
•             Abnormally high levels of activity like continuous talking, constant movement, and persistent restlessness.
•             The tendency to act on urges rather than on thought.
•             Difficulty paying attention.
ADHD can be treated with medications, behavioral therapy, or a combination of the two. If you are concerned that you or someone you know may have symptoms of ADHD, please consult your physician.


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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