FIRST GENERIC ZOLOFT LAUNCHED IN THE U.S.

Teva said Aug. 14 it has launched its generic version of Pfizer's blockbuster antidepressant Zoloft in the U.S. after a two-week delay caused by late-stage production issues.

The Israeli drug firm has begun selling 25-, 50- and 100-mg tablets of Zoloft (sertraline HCl), indicated for the treatment of major depressive disorder. As the first generic drugmaker that successfully challenged the Zoloft patent, Teva will be the only generic drugmaker allowed to sell those doses of the drug for the next six months. U.S sales of Zoloft were approximately $3.1 billion for the 12 months ending June 2006, Teva said, citing IMS Health data.

In its June 30 announcement that the FDA has granted final approval to Teva to make generic Zoloft, Teva said the company was "in receipt of final labeling and is making preparations to launch this product in the latter part of July."

"We had an enormous amount of product to put through the system, and we had some late-stage labeling issues that we needed to deal with," George Barrett, Teva's president and CEO, North America division, said during the company's second-quarter earnings call Aug. 8.

Teva President and CEO Israel Makov emphasized that the company did not deliberately delay the launch to boost earnings. "We never delay launch of a product just because we want to have a better distribution of sales or profits in quarters. It's not that. When we are ready, we go," he said during the call. (http://www.fdanews.com/did/5_159/)