FDA shoots down Mevacor OTC

It's official: Merck's off-patent statin drug Mevacor can't go over-the-counter. About a month after an advisory panel said "nay" to the idea [1], the FDA sent Merck a not approvable letter. It's the third time the agency has denied Merck's request to sell Mevacor without a prescription.

This time, there was an added wrinkle: GlaxoSmithKline had inked a deal with Merck [2] for the over-the-counter rights to Mevacor in the U.S. So Merck was asking the FDA for an OK on GSK's behalf. The panel's chief concern: that even Merck's own patient survey showed some who shouldn't be taking statins would choose to do so.

Merck's OTC group is now "evaluating the conditions outlined in the agency's response" to see where to tack next. The FDA asked for a revised label--and, most importantly, for additional data. We'll see what Merck can pull out of its hat.

- see the release [3]
- read the report [4] from CNN Money
- here's a PharmaTimes article [5]

Related Articles:
FDA panel: No can do on Mevacor OTC. Report [1]
FDA unsure consumers can self-Mevacor. Report [6]
Merck faces fierce debate on OTC statin. Report [7]
GSK buys OTC rights to Merck statin. Report [2]
Switching to generic statins not so healthy. Report [8]