Overview
Amphetamine, a compound discovered over 100 years ago, is one of the more restricted controlled drugs. It was previously used for a large variety of conditions and this changed until this point where its use is highly restricted. Amphetamine, with the chemical formula alpha-methylphenethylamine, was discovered in 1910 and first synthesized by 1927. After being proven to reduce drug-induced anesthesia and produce arousal and insomnia, amphetamine racemic mix was registered by Smith, Kline and French in 1935. Amphetamine structure presents one chiral center and it exists in the form of dextro- and levo-isomers. The first product of Smith, Kline and French was approved by the FDA on 1976. During World War II, amphetamine was used to promote wakefulness in the soldiers. This use derived into a large overproduction of amphetamine and all the surplus after the war finalized ended up in the black market, producing the initiation of the illicit abuse.
Indication
Amphetamine is indicated for the treatment of attention-deficit/hyperactivity disorders (ADHD) as well as for the treatment of central nervous system disorders such as narcolepsy. ADHD is a complex disorder associated with the substantial heterogeneity in etiology, clinical presentation, and treatment outcome. ADHD comes from a complex interplay between interdependent genetic and non-genetic factors which cause complex mental disorders in children and teenagers. On the other hand, narcolepsy is a chronic sleep disorder typically resenting during adolescence and characterized by excessive daytime sleepiness. Amphetamine is also being used nowadays off-label for the treatment of obesity, depression and chronic pain.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Chronic Pain
- Depression
- Narcolepsy
- Obesity
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/09/04 | Phase 1 | Completed | |||
2008/08/13 | Phase 1 | Completed | |||
2008/07/15 | Not Applicable | Completed | |||
2007/11/14 | Phase 3 | Completed | |||
2007/11/12 | Phase 2 | Completed | New River Pharmaceuticals | ||
2007/05/02 | Phase 4 | Completed | |||
2005/09/28 | Phase 4 | Completed | |||
2005/09/09 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lannett Company, Inc. | 0527-5513 | ORAL | 5.0 mg in 1 1 | 12/18/2019 | |
| Teva Pharmaceuticals USA, Inc. | 0555-0972 | ORAL | 2.5 mg in 1 1 | 8/1/2023 | |
| Bryant Ranch Prepack | 63629-2378 | ORAL | 3.75 mg in 1 1 | 7/24/2017 | |
| Camber Pharmaceuticals, Inc. | 31722-187 | ORAL | 3.75 mg in 1 1 | 10/21/2021 | |
| Bryant Ranch Prepack | 63629-9486 | ORAL | 1.875 mg in 1 1 | 3/2/2022 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1185 | ORAL | 2.5 mg in 1 1 | 12/17/2021 | |
| Aurolife Pharma, LLC | 13107-259 | ORAL | 5 mg in 1 1 | 1/31/2024 | |
| Camber Pharmaceuticals, Inc. | 31722-157 | ORAL | 2.5 mg in 1 1 | 9/28/2023 | |
| NorthStar RxLLC | 16714-954 | ORAL | 7.5 mg in 1 1 | 2/9/2023 | |
| ANI Pharmaceuticals, Inc. | 43975-281 | ORAL | 6.25 mg in 1 1 | 10/31/2023 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SANDOZ AMPHETAMINE XR | 02457288 | Capsule (Extended Release) - Oral | 5 MG | 12/22/2016 | |
| TARO-AMPHETAMINE XR | sun pharma canada inc | 02513900 | Capsule (Extended Release) - Oral | 15 MG | N/A |
| ADDERALL XR | takeda canada inc | 02248810 | Capsule (Extended Release) - Oral | 15 MG | 1/30/2004 |
| ADDERALL XR | takeda canada inc | 02248808 | Capsule (Extended Release) - Oral | 5 MG | 1/30/2004 |
| TARO-AMPHETAMINE XR | sun pharma canada inc | 02513919 | Capsule (Extended Release) - Oral | 20 MG | N/A |
| PMS-AMPHETAMINES XR | 02440415 | Capsule (Extended Release) - Oral | 30 MG | 1/16/2017 |
CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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