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news.Two new depression drug generics are set to hit the US market following the FDA's approval of both Teva's Zoloft generic and Par Pharmaceutical's copycat version of GlaxoSmithKline's Parnate.
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Beginning with Teva, the Israeli generics giant has received final FDA approval for its abbreviated new drug application (ANDA) to market a generic version of Pfizer’s Zoloft (sertraline) tablets, 25mg, 50mg, and 100mg.
Teva’s AB-rated sertraline tablets are indicated for the treatment of major depressive disorder.
As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity, which will start upon the initiation of a commercial launch. Teva is now in receipt of final labeling and is making preparations to launch this product before the end of July.
Par’s approval, meanwhile, relates to an ANDA submitted by its wholly-owned subsidiary, Kali Laboratories, for tranylcypromine sulfate tablets, 10mg. Tranylcypromine is the generic version of GlaxoSmithKline’s Parnate and is used for the treatment of depression.