ADELAIDE, South Australia--(BUSINESS WIRE)--Nov. 2, 1998-- International pharmaceutical and healthcare company, F H Faulding & Co Limited (Faulding), today announced that its US-based subsidiary, Purepac Pharmaceutical Co, part of Faulding Oral Pharmaceuticals, has received approval from the Food and Drug Administration (FDA) for its abbreviated new drug application for immediate-release isosorbide mononitrate tablets.
Mr Richard Moldin, Chief Executive Officer of Faulding Oral Pharmaceuticals, said, "Our 10mg and 20mg immediate-release isosorbide mononitrate tablets are the first generic equivalent of Monoket(R) brand tablets, marketed by Schwarz GMBH, to be approved by the FDA. The tablets are indicated for the prevention of angina pectoris due to coronary heart disease. The product had brand name sales in 1997 of approximately US$30 million. Purepac will commence commercial shipment of the product immediately."
The immediate-release isosorbide mononitrate tablets are the third FDA approval received by Faulding for the 1998/99 financial year, following the tentative approvals of diltiazem hydrochloride extended-release capsules and ticlopidine hydrochloride tablets.
Note: Monoket(R) is a registered trademark of Schwarz GMBH.
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