(Nasdaq, TASE:TEVA) yesterday said the United States Food and Drug Administration has approved the company's ANDA for Tizanidine HCl Tablets, 2 mg and 4 mg.
Shipments are to begin immediately, Teva said.
Tizanidine HCl is the generic equivalent of Ireland-based Elan Pharmaceuticals Zanaflex tablets, used in the treatment of muscle spasticity.
The brand product had annual sales of approximately $178 million, Teva said in a statement.
On July 1 Teva received FDA approvals for two drugs commanding a $2.2 billion annual market: lisinopril, the generic version of Prinivil. The other is lisinopril/HCTZ, the generic version of Prinizide, both made by Merck & Co (NYSE:MRK).
Also on July 1, Teva announced that it had completed its acquisition, for cash, of the French generic operations of Bayer Pharma S.A. - Bayer Classics S.A. and a production site located in Sens, France.
Bayer Classics, the third largest supplier of generic pharmaceuticals to the French retail market, will be named Teva Classics.
Teva, through the combination of its existing operations in France and the new operations, will offer the French market 72 generic products in 153 presentations, and will have 49 products in the pipeline of pending generic product registrations.