FDA Approves Generic Version of Adderall XR
Impax Laboratories, Inc. has received FDA approval of its Abbreviated New Drug Application for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules, CII, in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg doses. These products are indicated for the treatment of attention deficit hyperactivity disorder.
The generic Adderall XR capsules are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic animes (eg, angioedema), glaucoma, agitated states, history of drug abuse, and during or within 14 days following the administration of monoamine oxidase inhibitors.
According to IMS Health, US brand and generic sales of mixed amphetamine sales capsules in these doses accounted for $1.8 billion from November 2014 through November 2015.
In adults, the most adverse reactions were dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, dizziness, agitation, tachycardia, diarrhea, asthenia, and urinary tract infections.
In children, adverse reactions included loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. In adolescents, side effects included loss of appetite, insomnia, abdominal pain, weight loss, and nervousness.
