Re: FDA rejects combo allergy drug

California Poppy wrote:
On Apr 27, 9:20�am, Jim Higgins <gordian...@xxxxxxxxxxx> wrote:
FDA rejects combo allergy drughttp://tinyurl.com/54m6hq

KENILWORTH, N.J. (AP) -- The Food and Drug Administration has turned
down an application by two drugmakers to produce an allergy drug
combining the active ingredients of their popular Claritin and Singulair
tablets.

Schering-Plough/Merck Pharmaceuticals, a joint venture of
Kenilworth-based Schering-Plough (SGP, Fortune 500) and Whitehouse
Station-based Merck (MRK, Fortune 500), said late Friday that it had
received a not-approvable letter from the FDA.

Schering-Plough/Merck said it is evaluating the agency's response but
did not provide further details.

It filed an application for review of the proposed new drug in August 2007.

The FDA decision does not affect the availability or continued use of
either Singulair or Claritin.

The prescription allergy and asthma pill Singulair is among Merck's
best-selling products, with sales of $4.3 billion last year.

Schering Plough's Claritin, formerly a prescription drug, is off-patent
and is now sold over-the-counter.

--
Civis Romanus Sum

I can remember reading many years ago that when you add more
ingredients to any drug, you increase the chances of a reaction that
is bad for some people.

But...................by combining, they can create a 'new' prescription drug
that will help to replaces losses from Claritin's going off patent.
Making something new of two old products is probably as old as the
patent process.
.

Relevant Pages

  • FDA rejects combo allergy drug
    ... N.J. -- The Food and Drug Administration has turned down an application by two drugmakers to produce an allergy drug combining the active ingredients of their popular Claritin and Singulair tablets. ... Schering-Plough/Merck Pharmaceuticals, a joint venture of Kenilworth-based Schering-Plough and Whitehouse Station-based Merck, said late Friday that it had received a not-approvable letter from the FDA. ...
    (soc.senior.issues)
  • Re: FDA rejects combo allergy drug
    ... N.J. -- The Food and Drug Administration has turned ... down an application by two drugmakers to produce an allergy drug ... combining the active ingredients of their popular Claritin and Singulair ... Schering-Plough/Merck said it is evaluating the agency's response but ...
    (soc.senior.issues)
  • Re: FDA rejects combo allergy drug
    ... KENILWORTH, N.J. -- The Food and Drug Administration has turned ... down an application by two drugmakers to produce an allergy drug ... Schering-Plough/Merck said it is evaluating the agency's response but ...
    (soc.senior.issues)