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news.Two antidepressants have been dealt new generic blows, with Teva Pharmaceutical Industries announcing that it has begun selling its generic version of Pfizer's antidepressant Zoloft in the US, and Mylan Laboratories gaining tentative FDA approval for a copycat version of Wyeth's Effexor.
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Teva has begun selling 25mg, 50mg and 100mg sertraline tablets in the US. As the first company to file an abbreviated new drug application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Pfizer’s Zoloft is not the only big-selling antidepressant to come under attack by a generics firm recently. On the same day Teva announced that it had commenced sales of sertraline, Mylan Laboratories revealed that it has been granted a tentative approval from the FDA to market a generic version of Wyeth’s Effexor (venlafaxine hydrochloride) in the US. Mylan’s tentative approval covers 25mg (base), 37.5mg (base), 50mg (base), 75mg (base) and 100mg (base) tablet strengths.
Both Teva’s AB-rated Sertraline Tablets and Mylan’s AB-rated Venlafaxine HCl Tablets are indicated for treatment of major depressive disorder.