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Published on 9/12/2006 in the Prospect News Biotech Daily.

KV Pharmaceutical gets FDA OK to sell generic Tiazac for hypertension

By Elaine Rigoli

Tampa, Fla., Sept. 12 - KV Pharmaceutical Co. said it has received approval from the Food and Drug Administration to market six strengths of Diltiazem HCl ER capsules, a generic version of Forest Pharmaceuticals, Inc.'s Tiazac, through its wholly owned generic/non-branded subsidiary, Ethex Corp.

Ethex will begin shipments of all six strengths immediately.

Tiazac is indicated for the treatment of hypertension and angina. Total market sales for this product are roughly $160 million, according to a KV Pharmaceutical news release.

KV Pharmaceutical is a specialty pharmaceutical company based in St. Louis. It believes it is the first generic company to receive approval of the 420 mg strength dosage and thus expects to have six months exclusivity on this strength.


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