KV Pharmaceutical (KV.a) Receives FDA Approval for Marketing of Six Strengths of Diltiazem HCl ER
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KV Pharmaceutical Company (NYSE: KV.a) has received approval from the U.S. Food and Drug Administration to market six strengths of Diltiazem HCl ER Capsules through its wholly-owned generic/non-branded subsidiary, ETHEX Corporation. ETHEX will begin shipments of all six strengths immediately.
KV also believes it is the first generic company to receive approval of the 420mg strength dosage, and thus expects to have six months exclusivity on this strength. However, it is also expected that the brand manufacturer may launch an "authorized generic" version. Total market sales for this product are approximately $160 million. Tiazac is indicated for the treatment of hypertension (high blood pressure) and angina (chest pain).
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