December 02, 2015
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Mylan releases generic Adderall tablets in US

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Mylan recently announced the U.S. launch of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, the generic version of Teva Pharmaceutical’s Adderall tablets.

Mylan received final FDA approval for its Abbreviated New Drug Application for 5-mg, 7.5-mg, 10-mg, 12.5-mg, 15-mg, 20-mg and 30-mg tablets, which are indicated for treatment of attention-deficit/hyperactivity disorder.

According to IMS Health, 5-mg, 7.5-mg, 10-mg, 12.5-mg, 15-mg, 20-mg and 30-mg dosages of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets had U.S. sales of approximately $570.4 million for the 12 months prior to Sept. 30, 2015.

Mylan currently has 253 Abbreviated New Drug Applications pending FDA approval, representing $100.8 billion in annual brand sales, according to IMS Health.