Tentative approval of testosterone gel product

Par Pharmaceutical Companies today announced that its partner, Paddock Laboratories, has been granted tentative approval by the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for testosterone gel 1%.

Unimed Pharmaceuticals currently markets testosterone gel 1% under the brand name AndroGel(R). AndroGel(R) is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. The product has annual U.S. sales of approximately $300 million.

Paddock filed an ANDA containing a paragraph IV certification with the FDA in May 2003 seeking marketing clearance for its generic version of AndroGel(R). Par believes Paddock was the first to file and is entitled up to 180 days of marketing exclusivity for the product. It should be noted that it is difficult to know with certainty that an ANDA filing has exclusivity until final approval is received from the FDA.

In July 2003, Par entered into a licensing agreement with Paddock to market testosterone gel 1% in the U.S. Paddock will manufacture the product.

A tentative approval reflects the FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of any patents or exclusivity periods accorded to the reference listed drug. A tentative approval does not allow the applicant to market the generic product and postpones the final approval until all patent/exclusivity issues have expired.

Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and its recently acquired subsidiary, Kali Laboratories, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets and expects to introduce the first of these in 2005. Through its FineTech subsidiary, Par also develops and utilizes synthetic chemical processes to design and develop intermediate ingredients used in the production of finished products for the pharmaceutical industry. Par currently manufactures, markets or licenses more than 80 prescription drugs.