Elan announces approval of new versions of Skelaxin™ and Tizanidine
DUBLIN, IRELAND, September 4, 2002 -- Elan Corporation, plc (NYSE: ELN) (“Elan”) today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application (sNDA) for an 800 mg strength SkelaxinÔ (metaxalone) tablet and a new drug application (NDA) for 2 mg, 4 mg and 6 mg tizanidine hydrochloride in capsule presentations. The capsule presentation represents a new formulation of Elan’s currently marketed ZanaflexÔ (tizanidine hydrochloride) tablets.
Skelaxin is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. Tizanidine is indicated for the management of spasticity.
Elan is focused on the discovery, development, manufacturing, selling and marketing of novel therapeutic products in neurology, pain management and autoimmune diseases. Elan shares trade on the New York, London and Dublin Stock Exchanges.
This news release may contain certain forward-looking statements by Elan that involve risks and uncertainties and reflect the company’s judgement as of the date of this release. Actual events or results may differ from the company’s expectations. For example, there can be no assurance that these new products, Skelaxin and tizanidine, will be successfully manufactured, launched or marketed. A further list of these risks, uncertainties and other matters can be found in Elan’s Annual Report on Form 20-F for the fiscal year ended December 31, 2001, and in its Reports of Foreign Issuer on Form 6-K. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Link:http://www.elan.com/NewsRoom/NewsYear2002/09042002.asp?ComponentID=2686&SourcePageID=2338#1 |
