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REGULATORY NEWS: Richwood's Adderall

Executive Summary

Richwood's Adderall: Attention-deficit/hyperactivity disorder therapy Adderall (mixed salts of a single-entity amphetamine) is approved by FDA Feb. 13, the Florence, Kentucky specialty manufacturer and marketer announces. The drug will be available in 10 mg and 20 mg double-scored tablets in March, indicated for "treatment of narcolepsy, attention-deficit disorder with hyperactivity and exogenous obesity." The most frequently reported adverse reactions are "anorexia, insomnia, stomach pain, headache, irritability and weight loss," Richwood reports. Adderall potentially can cause growth suppression, precipitate motor tics and Tourette's Syndrome and "in rare cases exacerbations of psychosis have been reported." Richwood obtained Adderall through its acquisition of Rexar, which marketed the drug for treatment of obesity and ADHD as Obetrol. Obetrol was withdrawn from the market in 1973 under the DESI statute; Rexar reformulated the drug and continued marketing it without an approved sNDA. Richwood withdrew Adderall from the market following an FDA warning letter in October 1994 and submitted the drug as NDA 11-522...

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