News + Font Resize -

Ivax's Tizanidine HCL tabs, brimonidine tartrate ophthalmic solution approved
Miami | Monday, October 4, 2004, 08:00 Hrs  [IST]

Ivax Corporation has received final approval from the Federal Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for tizanidine HCl in 2 mg and 4 mg tablet dosages. These tablets will be sold through the company's wholly owned subsidiary, Ivax Pharmaceuticals Inc.

Tizanidine HCl tablets are the generic equivalent of Zanaflex, which is marketed by Elan Pharmaceuticals as a muscle relaxant. According to IMS data, US sales of Zanafelx and generic tizanidine HCl tablets in 2 mg and 4 mg dosage forms are approximately $119 million for the past twelve months, ending June 30, 2004.

Earlier, Ivax had announced that it had received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for brimonidine tartrate ophthalmic solution, 0.2%. Brimonidine tartrate ophthalmic solution, 0.2% is the generic equivalent of Alphagen, which is marketed by Allergan and used in the treatment of glaucoma.

Post Your Comment

 

Enquiry Form