Generic, authorized generic of Amrix launched

PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.

As the first company to file for Food and Drug Administration approval of a generic version of Amrix, Mylan will have 180 days of market exclusivity in which to compete directly with the branded version, under the provisions of the Hatch-Waxman Act of 1984, the law that created a regulatory approval pathway for generic pharmaceutical drugs.

In related news, Watson subsidiary Watson Pharma has launched an authorized generic of Amrix in the 15-mg and 30-mg strengths, as part of an agreement with Anesta AG, a subsidiary of Cephalon. Under the terms of the nonexclusive sales agent agreement, Anesta manufactures and supplies Watson with all dosage strengths of the authorized generic product.

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