FDA approves generic lisinopril for five drugmakers

Alpharma of the USA's subsidiary Purepac Pharmaceutical has receivedapproval from the US Food and Drug Administration to manufacture and market lisinopril and hydrochlorothiazide tablets, 10mg/12.5mg, 20mg/12.5mg, 20mg/25mg. The company expects to launch immediately. Alpharma's products, to be marketed under the Purepac brand, are the generic equivalent of Prinzide, originated by Merck & Co. Prinzide is indicated for the treatment of hypertension. Total brand sales for lisinopril & hydrochlorothiazide tablets for the year ended December 2001 were approximately $286 million.

Also receiving FDA approval for generic lisinopril and HCl were Teva, Ivax, Watson and Eon Pharmaceutical, with the first three also gaining clearance for generic versions of AstraZeneca's Zestril (lisinopril).