FDA Approves Roxane ANDA For Perindopril Erbumine Tablets

Published: 11-Nov-2009

For the treatment of patients with essential hypertension

Roxane Laboratories (Roxane) has received approval for its Abbreviated New Drug Application (ANDA) for Perindopril Erbumine tablets, 2mg, 4mg and 8mg from the FDA.

Perindopril Erbumine tablets are the generic equivalent of Solvay's Aceon tablets, which falls under the CVS segment and indicated for the treatment of patients with essential hypertension.

The tablets are the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Its molecular formula is C19H32N2O5C4H11N.

The company said that the product is available in bottles of 100 for immediate shipment to wholesalers and pharmacies nationwide.

Roxane's Perindopril Erbumine tablets are AB rated to Aceon (Perindopril Erbumine) tablets.

Aceon tablets is available for oral administration. In addition to perindopril erbumine, each tablet contains the inactive ingredients: colloidal silica (hydrophobic), lactose, magnesium stearate and microcrystalline cellulose. The 4mg and 8mg tablets also contain ironoxide.

No items to display

Tell your friend about this article