Trade Resources Industry Views FDA Has Granted Regulatory Approval to Actavis's Diltiazem HCL Extended-Release Capsules

FDA Has Granted Regulatory Approval to Actavis's Diltiazem HCL Extended-Release Capsules

The US Food and Drug Administration (FDA) has granted regulatory approval to Actavis' Diltiazem Hydrochloride (HCL) extended-release capsules.

Actavis' Diltiazem HCL capsules are generic equivalent of Valeant's cardiovascular drug, Tiazac.

Tiazac is a calcium ion cellular influx inhibitor which produces anti-hypertensive effect by relaxing vascular smooth muscles.

The Actavis' generic Tiazac is available in 120mg, 180mg, 240mg, 300mg, 360mg, and 420mg dosage strengthens.

According to IMS Health, Tiazac, and its generic equivalents, had US sales of approximately $76.3m for the 12 months ending 31 December 2011.

Other manufactures of generic Tiazac include Nesher Pharms, Apotex, Watson Laboratories.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-actavis-generic-cardiovascular-drug-111012
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FDA approves Actavis generic cardiovascular drug