The US Food and Drug Administration has granted tentative approval for Alpharma's ANDA for sertraline hydrochloride 25 mg, 50 mg, and 100 mg tablets.

Alpharma's sertraline hydrochloride tablets are the AB-rated generic equivalent of Pfizer's Zoloft tablets, a product indicated for several disorders, including depression. Zoloft tablet sales in 2004 were approximately $3 billion.

According to a company release, this tentative approval was received by the company's US generic business. On October 17, 2005, the reached a definitive agreement to sell both its US and international generics businesses to Actavis Group.

Alpharma Inc. is a global specialty pharmaceutical company with leadership positions in products for humans and animals.