Merck receives FDA approval for prostaglandin analog ophthalmic solution
Merck, known as MSD outside the US and Canada, has received FDA approval for ZIOPTAN (tafluprost ophthalmic solution) 0.0015%, the preservative-free prostaglandin analog ophthalmic solution.
ZIOPTAN (pronounced zye-OP-tan) is approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension.
The FDA approval of ZIOPTAN was based on efficacy and safety results from five controlled clinical studies of up to two years in 905 patients, the company said.
Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies.
Merck expects to launch ZIOPTAN in March 2012.
Merck Research Laboratories neurology and ophthalmic therapeutic area vice president David Michelson said that ZIOPTAN is the first preservative-free prostaglandin analog.
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
This report is a crucial resource for industry executives and anyone looking to access key information about "Shire Plc" The report utilizes a wide range of primary and secondary sources, which are analyzed and presented in a consistent and easily accessible format. ICD Research strictly follows a standardized research methodology to ensure high levels of data quality and these characteristics guarantee a unique report. Buy online from $250