Generic-drug maker Teva Pharmaceutical Industries Ltd. announced that it has received final FDA approval to market fluoxetine, for treatment of a premenstrual disorder.
The drug is the generic equivalent of Eli Lilly's Sarafem Pulvules, used to treat premenstrual dysphoric disorder, a condition affecting 3 percent to 8 percent of women of reproductive age in the United States. The disorder, a severe form of premenstrual syndrome, is characterized by intense emotional symptoms, including irritability and depressed mood.
The brand name Lilly product had annual sales of about $39 million in the United States for the 12 months that ended March 31, the company said, citing research from market research company IMS.
Teva, which is based in Israel, has North American headquarters in North Wales.
Teva was awarded an exclusive 180-day period of marketing by the Food and Drug Administration because it was the first first company to file an abbreviated new drug application for this product.