DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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FEB 14 2013, Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for the generic version of Shire’s Adderall XR®Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder. Adderall XR® had annual sales, including brand and generic sales, of approximately $2 billion in the United States, based on IMS sales data as of December 31, 2012.
Teva currently sells a generic version of Adderall XR® Capsules under a 2006 license and distribution agreement with Shire as part of a settlement of patent litigation between Shire and Teva’s subsidiary Barr Pharmaceuticals. Under the terms of the agreement, Teva has the right to be supplied product by Shire through April 1, 2014.
Adderall is a psychostimulant medication that contains amphetamine. It is used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.[1] Adderall is a combination of four amphetamine salts (racemic amphetamine aspartate monohydrate, racemic amphetamine sulfate, dextroamphetamine saccharide, and dextroamphetamine sulfate). It is a dopamine releasing agent, a norepinephrine releasing agent, and can be mildly serotonergic.[2] It is available in two formulations: IR (Instant Release) and XR (Extended Release). The immediate release formulation is indicated for use in attention deficit hyperactivity disorder (ADHD) and narcolepsy,[3] while the XR formulation is approved for use only with attention deficit hyperactivity disorder (ADHD).[2]
Important side effects of therapeutic dextroamphetamine include stunted growth in young people and occasionally a psychosis can occur at therapeutic doses during chronic therapy as a treatment emergent side effect.[4] When abused at high doses, the risk of experiencing side effects and the severity of side effects increases. Side effects may include sweating or shaking.
Like other stimulant drugs, such as methamphetamine and cocaine, Adderall directly affects the mesolimbic reward pathway in the brain. Amphetamine salt preparations are considered to have high abuse potential, and it is classified as Schedule II by the US DEA. With the Safe Streets and Communities Act in Canada, Adderall has been reclassified from Schedule III to Schedule I.[5]
- “Adderall”. The American Society of Health-System Pharmacists. http://www.drugs.com/monograph/adderall.html. Retrieved 3 April 2
- “Adderall XR prescribing information”. Shire US. March 2009. http://pi.shirecontent.com/PI/PDFs/AdderallXR_USA_ENG.PDF. Retrieved 2009-06-23.
- “ADDERALL (CII)” (PDF). Food and Drug Administration. February 2007. http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf. Retrieved 2009-06-23.
- Berman, SM.; Kuczenski, R.; McCracken, JT.; London, ED. (Feb 2009). “Potential adverse effects of amphetamine treatment on brain and behavior: a review.”. Mol Psychiatry 14 (2): 123–42. doi:10.1038/mp.2008.90. PMID 18698321.
- C-10
| Combination of | |
|---|---|
| Dextroamphetamine | Psychostimulant |
| Amphetamine | Psychostimulant |
| Clinical data | |
| Trade names | Adderall, Adderall XR |
| AHFS/Drugs.com | monograph |
| MedlinePlus | a601234 |
| Licence data | US Daily Med:link |
| Pregnancy cat. | C (US) |
| Legal status | Schedule I (CA) Schedule II (US) |
| Dependence liability | High |
| Routes | (Medical) Oral, (Recreational) Oral, Insufflated, Intravenous |
| Identifiers | |
| CAS number | 51-64-9 300-62-9 |
New Drug Approvals 
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