Troubled pharmaceutical company Elan has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application for the relief of discomforts associated with acute, painful musculoskeletal conditions.
Elan says the FDA has approved new drug applications for a Skelaxin tablet and a number of tizanidine capsules.
The FDA gave the green light to the 800 mg strength Skelaxin tablet and a new drug application for 2 mg, 4 mg and 6 mg tizanidine hydrochloride in capsule presentations.
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.
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.