Actavis' Subsidiary Amide Receives FDA approval for Mirtazapine ODT


REYKJAVIK, Iceland, Sept. 5, 2005 (PRIMEZONE) -- Actavis Group hf.("ACT") today announces that Amide Pharmaceutical Inc., a subsidiary of Actavis Group in New Jersey USA, has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Mirtazapine orally disintegrating tablets (ODT) 15 mg, 30 mg and 45Mirtazapine ODT is the generic version of Organon's Remeron SolTab(R) and is indicated for the treatment of major depressive disorder. As one of the first two applicants 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 US$100 million. Amide will manufacture, market, sell and distribute Mirtazapine ODT in the U.S. and will begin shipping Mirtazapine ODT 15 mg, 30 mg and 45 mg tablets shortly.

Amide Pharmaceutical, Inc., located in Little Falls, New Jersey, develops, manufactures and markets a select line of high quality pharmaceuticals. The company was acquired by Actavis Group hf. in May 2005. The product is expected to have insignificant material effect on Actavis' financials for 2005.

For more information, please contact Halldor Kristmannsson, Director of Corporate Communications, tel. +354 535 2325

Actavis Group is an international pharmaceutical company, founded in 1956, specialising in the development, manufacture and sale of generic pharmaceuticals. Headquartered in Iceland, Actavis employs around 7,000 people worldwide and has operations in 28 countries with development and manufacturing facilities in Iceland, Bulgaria, Turkey, Malta, Serbia and the USA.

Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.



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