Santarus PPI could be future Merck switch
This article was originally published in The Tan Sheet
Merck's Schering-Plough consumer products unit would have OTC switch rights to a Santarus dual-buffer prescription proton pump inhibitor if FDA approves it under the Zegerid brand. The agency approved Santarus' immediate-release omeprazole/sodium bicarbonate/magnesium hydroxide prescription drug for treatment of heartburn and other symptoms of gastroesophageal reflex disease in 20-mg and 40-mg doses, the San Diego firm said Dec. 4. If FDA approves a new drug application supplement requesting the drug's name include the Zegerid brand, as Santarus expects, Merck can apply to switch it to OTC, a Santarus spokeswoman said. The Rx announcement follows FDA's approval of Zegerid OTC, set to launch in 2010 (1"The Tan Sheet" Dec. 7, 2009)
You may also be interested in...
Merck's Schering-Plough Consumer HealthCare Products division will launchZegerid OTC in the first half of 2010 as the first dual-ingredient OTC proton pump inhibitor
Discussing the latest developments in the US biosimilars market, AmerisourceBergen’s senior director of biosimilar commercialization, Brian Biehn, talks about what we can expect from competition to Humira in 2023, how the first ophthalmology biosimilars are faring, and potential changes on the horizon at the FDA that could smooth the path to market for biosimilars sponsors.
The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.