The Perrigo Company, through a partnership with InvaGen Pharmaceuticals has received tentative approval from the US Food and Drug Administration (FDA) to market sertraline hydrochloride tablets, 25 mg, 50 mg and 100 mg. The final approval is subject to the expiration of any applicable exclusivity period enjoyed by another ANDA filer for the same product.

According to the company release, the product is equivalent to Pfizer's Zoloft tablets, 25 mg, 50 mg and 100 mg, indicated for the treatment of depression, and obsessive-compulsive and panic disorders.

Annual US sales for the brand are approximately $3 billion, according to NDC data.

The Perrigo Company is a leading global healthcare supplier and the world's largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market.