SPRING VALLEY, N.Y., Sept. 16 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) seeking marketing clearance for megestrol acetate oral suspension NanoCrystal(R) Dispersion (NCD). The assigned filing date for the NDA is August 28, 2004 with a corresponding user fee goal date of April 29, 2005. On June 29, 2004, Par submitted the NDA, pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
The new NCD formulation is a line extension of Par's currently marketed megestrol acetate oral suspension. This advanced formulation utilizes NanoCrystal(TM) Dispersion technology to improve the bioavailablity of the drug, compared to currently available formulations of the product. NanoCrystal(R) Dispersion is a trademark of Elan Corporation, plc, Dublin, Ireland. If cleared for marketing, megestrol acetate oral suspension NCD is expected to be indicated for the treatment of anorexia, cachexia, or any unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
Megestrol acetate oral suspension is the generic version of Bristol-Myers Squibb Company's Megace(R) Oral Suspension. In 2003, Par licensed the Megace(R) brand name from Bristol-Myers Squibb for its new NCD formulation of the drug.
Megestrol acetate oral suspension NCD appears to achieve therapeutic plasma concentrations in fasting as well as fed subjects. Par's studies have indicated minimal food effect with the new NCD formulation as compared with existing formulations of megestrol acetate oral suspension. This is of particular significance when treating anorectic or cachectic patients who are typically in a fasted state. Megestrol acetate oral suspension NCD will be administered through the more convenient dosing of a lower volume of drug. Patients are administered a teaspoon of the new NCD formulation once daily, as compared with drinking a once-daily 20 mL dosage cup of the current formulation.
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. For press release and other company information, visit http://www.parpharm.com/.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.