Par Formulations (formerly Edict Pharmaceuticals) announced its first FDA approval for Labetalol HCl Tablets, the generic version of Prometheus Labs’ Trandate tablets.

Labetalol HCl is a noncardioselective β-blocker/α1-blocker indicated for the management of hypertension. β-blockers decrease cardiac rate, force of contraction and output, and renin secretion. α-blockers lower blood pressure by arteriolar dilation mediated by antagonism of post-synaptic α1-adrenergic receptors.

Labetalol HCl Tablets will be available from Par in 100mg, 200mg, and 300mg dosage strengths in August 2012.  

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