Drugs
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FDA Asks Attention-Deficit Hyperactivity Disorder (ADHD) Drug Manufacturers to Develop Patient Medication Guides
FDA has directed the manufacturers of all drug products approved for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) to develop patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.
- FDA Press Release (issued February 21, 2007)
- Advisory Committee Transcripts
- Drug Safety and Risk Management Advisory Committee, February 9, 2006
- Pediatric Advisory Committee, March 22, 2006
Drugs
Note: This page links to PDF files which require the free Adobe Acrobat Reader.
| Adderall (mixed salts of a single entity amphetamine product) Tablets | Medication Guide | Label |
| Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules | Medication Guide | Label |
| Concerta (methylphenidate hydrochloride) Extended-Release Tablets | Medication Guide | Label |
| Daytrana (methylphenidate) Transdermal System | Medication Guide | Label |
| Desoxyn (methamphetamine hydrochloride) Tablets | Medication Guide | Label |
| Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets | Medication Guide | Label |
| Focalin (dexmethylphenidate hydrochloride) Tablets | Medication Guide | Label |
| Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules | Medication Guide | Label |
| Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules | Medication Guide | Label |
| Methylin (methylphenidate hydrochloride) Oral Solution | Medication Guide | Label |
| Methylin (methylphenidate hydrochloride) Chewable Tablets | Medication Guide | Label |
| Ritalin (methylphenidate hydrochloride) Tablets | Medication Guide | Label |
| Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets | Medication Guide | Label |
| Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules | Medication Guide | Label |
| Strattera (atomoxetine hydrochloride) Capsules | Medication Guide | Label |
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