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FDA approves new drug application for prostaglandin analogue

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WHITEHOUSE STATION, N.J. — The U.S. Food and Drug Administration has approved Merck's new drug application for tafluprost to lower IOP in patients with primary open-angle glaucoma or ocular hypertension, the company announced in a press release.

Saflutan (tafluprost) is an investigational preservative-free prostaglandin analogue ophthalmic solution that could help increase drainage of the aqueous humor.

Merck and Santen have a worldwide licensing agreement for the drug, which has already been approved in several European countries. If Saflutan is approved in the U.S., Santen would have the option of co-promoting the product, the release said.