Pharmaceutical Resources Inc a developer, manufacturer and distributor of generic pharmaceutical products, announced that Par Pharmaceuticals, a wholly owned subsidiary, has received tentative Federal Drug Administration ("FDA") approval for megestrol oral suspension.

A tentative approval is issued by the FDA at the satisfactory conclusion of the regulatory review process. The final approval will typically be granted following the court resolution of the patent infringement litigation between Par and Bristol-Myers Squibb (BMS) to determine whether or not Par's patented product formulation infringes the existing BMS patent formulation, or when instructed by court order.

The tentative approval is an important milestone for Par and is a significant development that signifies Par's eventual right to market the product. Megestrol oral suspension sales have been growing at a rate of nearly 40 percent over the past six months. According to published reports by Bristol-Myers Squibb, Megace brand oral suspension had sales of $75 million in the first six months of 2000. Par projects annual 2000 sales of the brand to exceed $150 million.

The timing of the ultimate marketing of megestrol oral suspension by Par and Par's six-month exclusivity is now dependent upon the current patent litigation with Bristol-Myers. Although BMS may be able to deter Par from entering the market through the litigation process until February 2002, Par believes it may enter the market prior to that date. However, it is difficult to target an actual launch date. Par has also sued Bristol-Myers for unfair competition in connection with its efforts to delay Par's marketing of this product.

Par's proprietary megestrol oral suspension formulation was developed by Par at its Spring Valley Research and Development Center and is not subject to profit sharing arrangements through any of its strategic alliances. The United States Patent and Trademark Office has granted a patent to Par that covers the unique formulation.

Megace brand oral suspension is currently prescribed for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).