Schering-Plough has announced a submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for ZEGERID(R) (omeprazole/sodium bicarbonate) in the dosage strength of 20 mg of omeprazole as a branded over-the-counter (OTC) product to treat frequent heartburn.
John E. O'Mullane, B.Sc., Ph.D., group vice president, Research and Development, Schering-Plough Consumer Health Care has said that Schering-Plough is looking forward to work , with the FDA to bring this prescription product to consumers as an OTC treatment for frequent heartburn.The approval for the approved ZEGERID will be a valuable addition to expand portfolio of gastrointestinal OTC products such as MiraLAX(R), which was launched last year for the treatment of occasional constipation.
