Ayerst's Inderene LA
Executive Summary
Firm submitted ANDA suitability petition for combination of long-acting propranolol plus hydrochlorothiazide with triamterene. Ayerst plans to market capsules in 80/50/75 mg, 120/50/75 mg, and 160/50/75 mg strengths as a "convenient alternative for those patients previously stabilized on a therapeutic regimen of one Inderal LA capsule and one Maxzide tablet daily." The petition cites recent survey data indicating that concomitant use with hydrochlorothiazide/triamterene accounts for 7.7% of total propranolol use.