Par Approved for Generic Trandate Tablets

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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