The Perrigo Company has received approval from the FDA to manufacture and market over-the-counter famotidine tablets.
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The FDA has determined that Perrigo's famotidine tablets, is bioequivalent to Maximum Strength Pepcid AC tablets distributed by Johnson & Johnson and Merck & Co. Famotidine is indicated for the prevention and relief of heartburn due to acid indigestion.
Shipments of famotidine will begin immediately. Annual retail sales for Maximum Strength Pepcid AC tablets are estimated to be approximately $60 million.
The Perrigo Company is a leading global healthcare supplier and a large manufacturer of over-the-counter pharmaceutical and nutritional products for the store brand market. The company also develops, manufactures and markets prescription generic drugs, active pharmaceutical ingredients and consumer products.