Claritin/Singulair Update: Merck Says Safety Isn't the Issue

We don't know what the issue with the Schering-Plough/Merck combination is, but now we know what it isn't.

Merck called us in response to our post on the "not approvable" letter for a fixed-dose combination of the blockbusters Singulair and Claritin. The letter, Merck says, did not raise any safety or tolerability issues.

We speculated that the letter must have had something to do with a recent notice from FDA suggesting a possible connection between Singulair and suicidality. Apparently that is not the issue--though we still suspect that whatever the issue is may have seemed weightier with that concern in the background.

Merck also pointed out that--contrary to what our post implied--the Singulair/Claritin combo is being developed under its own partnership agreement, separate from the Vytorin joint venture. Our bad.

We still think our point is valid: there is no such thing as a "low-risk" drug development plan.


Just ask Merck about Cordaptive....