The leading web portal for pharmacy resources, news, education and careers

June 18, 2013

Pharmacy Choice - Pharmaceutical News - United States : TEVA QUARTETTE new drug application approved [TendersInfo (India)] - June 18, 2013

Pharmacy News Article

8/17/12 - United States : TEVA QUARTETTE new drug application approved [TendersInfo (India)]

A US-based subsidiary of Teva Pharmaceutical Industries, Teva Women's Health has announced FDA approval of its Quartette new drug application (NDA).

The firm is seeking approval to produce and market Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), the first ascending-dose, extended regimen oral contraceptive for the avoidance of pregnancy.

Teva Women's Health R&D clinical affairs senior director Nancy Ricciotti said: Quartette builds upon our heritage in providing women with innovative, extended-cycle contraceptive products and we look forward to the potential to offer the first ascending-dose extended regimen birth-control option.

The submission was based on a clinical development program comprising results from Phase I, Phase II, and Phase III clinical trials which comprised over 3,000 female subjects and were aimed to assess the safety and efficacy of Quartette in the prevention of pregnancy.