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news.The FDA has given its final approval for Teva Pharmaceutical Industries' abbreviated new drug application for paroxetine hydrochloride tablets in 10mg, 20mg, 30mg and 40mg dosages.
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The tablets are an AB-rated generic equivalent of GlaxoSmithKline’s antidepressant Paxil.
New drug applications for generic drugs are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
Teva Pharmaceutical Industries is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva’s sales are in North America and Europe.