Faulding Receives USA FDA Tentative Approval for Bisoprolol Fumerate and Hydrochlorothiazide Tablets 2.5 mg / 6.25 mg, 5 mg / 6.25 mg and 10 mg / 6.25 mg

Business Wire, May 17, 2000

Business Editors/Health Writers

ADELAIDE, South Australia--(BUSINESS WIRE)--May 17, 2000

International pharmaceutical and health care company F H Faulding & Co Limited (Faulding), today announced that its US based oral generic business, Purepac Pharmaceutical Co (Purepac), part of the Faulding Oral Pharmaceuticals division, has received a tentative approval from the Food and Drug Administration (FDA) to manufacture and market bisoprolol fumerate and hydrochlorothiazide tablets in 2.5 mg / 6.25 mg, 5 mg / 6.25 mg and 10 mg / 6.25 mg strengths. The product is Purepac's generic version of Lederle's Ziac(R) brand tablets, indicated for the treatment of hypertension.

Frank Condella, Jr, Chief Executive Officer of Faulding Oral Pharmaceuticals said that "Purepac's tentative approval provides the Company with the opportunity to participate in the formation of the generic market for bisoprolol fumerate and hydrochlorothiazide tablets. Brand sales for bisoprolol fumerate and hydrochlorothiazide tablets are estimated to be in excess of US$190 million for the last 12 months. Final FDA approval and Purepac's commercial launch of Purepac's bisoprolol fumerate and hydrochlorothiazide tablets are scheduled to commence immediately upon expiration of paediatric exclusivity on 24 September 2000."

This tentative approval is the fourth FDA approval received by Purepac this fiscal year, and Purepac currently has eight applications on file with the FDA.

Faulding is a world-wide health and personal care company, listed on the Australian Stock Exchange. Faulding's principal businesses are generic oral and injectable pharmaceuticals, consumer health products, the provision of distribution and retail management services to pharmacies and logistics management services to hospitals. Faulding markets its products to and has representation in over 70 countries.

NOTE: Ziac(R)is a registered trademark of American Cyanamid Company.

N.B. Faulding Company Announcements are posted to the Faulding website www.faulding.com