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Par Pharmaceutical's Partner Receives Final Approval To Market Mirtazapine Orally Disintegrating Tablets

Posted on: Thursday, 1 September 2005, 12:00 CDT

SPRING VALLEY, N.Y., Sept. 1 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that its licensing partner, Amide Pharmaceutical, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for mirtazapine orally disintegrating tablets (ODT) 15 mg, 30 mg and 45 mg. The product was developed by Par's wholly-owned subsidiary, Kali Laboratories, Inc. Mirtazapine ODT is the generic version of Organon's Remeron SolTab(R) and is indicated for the treatment of major depressive disorder.

As one of two applicants first to file an ANDA containing a paragraph IV certification, Amide has been awarded 180 days of shared marketing exclusivity for the 45 mg dosage strength. An authorized generic version of the 45 mg strength was launched in October 2004. Annual U.S. sales of mirtazapine ODT tablets are approximately $90 million. Amide will begin shipping mirtazapine ODT 15 mg, 30 mg and 45 mg tablets shortly.

Under the terms of the agreement, Amide will manufacture, market, sell and distribute mirtazapine ODT in the U.S. Par will receive a royalty on sales of the product.

Amide Pharmaceutical, Inc., a subsidiary of Actavis Group hf, located in Little Falls, New Jersey, develops, manufactures and markets a select line of high quality pharmaceuticals.

Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products, the first of which is Megace(R) ES, for specialty markets. Par currently manufactures, markets or licenses more than 90 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.

CONTACT: Stephen J. Mock, or Cecelia C. Heer, both of Par PharmaceuticalCompanies, Inc., +1-201-802-4000

Web site: http://www.parpharm.com/

Source: PRNewswire-FirstCall

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