Acorda Therapeutics, Inc. has received a Paragraph IV Certification Notice from Apotex Inc. advising that it has filed an Abbreviated New Drug Application (ANDA) for generic versions of the three zanaflex capsules (tizanidine hydrochloride) dosage strengths.
The company is reviewing the Notice of Certification. Acorda continues to have full confidence in its intellectual property protecting zanaflex capsules.
Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The company's marketed products include zanaflex capsules (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical product, Fampridine-SR, is in a phase III clinical trial to evaluate its safety and efficacy in improving walking ability in people with MS. The company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.