FDAnews Drug Daily Bulletin

FDA Approves First Strattera Generic for ADHD, Plus Five Other First-Time Generics

June 6, 2017

The FDA approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit hyperactivity disorder in pediatric and adult patients, including multiple strengths manufactured by Apotex, Teva, Aurobindo Pharma and Glenmark Pharmaceuticals.

Strattera joins five other first-time generics approved by the agency in May, including treatments for Parkinson’s disease, pediatric leukemia, osteoarthritis pain and schizophrenia.

The agency approved Mylan’s generic moxifloxacin, known as the antibiotic Avelox, for treating certain bacterial infections. Mylan also received approval for its Azilect (rasagiline) tablets for Parkinson’s disease.

The FDA also approved four separate ANDAs for Seroquel XR (quetiapine fumarate) — submitted by IntelliPharmaCeutics, Par, Pharmadax and Accord Healthcare — for the treatment of schizophrenia, bipolar disorder and major depressive disorder.

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