February 11, 2009 9:10 PM
- Text
Itching To Sell Claritin Over-The-Counter
(AP)
If the government lets prescription Claritin begin selling as over-the-counter allergy relief, its makers might advertise aid for hives, too.
Advisers to the Food and Drug Administration voted Monday that enough evidence exists that Claritin can treat chronic hives without a sufferer needing a prescription.
FDA's advisers last year ruled that Claritin and two competing products Pfizer's Zyrtec and Aventis' Allegra should be sold as over-the-counter allergy relievers. The FDA has said it agrees with that advice but has issued no ruling.
All three companies originally had resisted the switch. But Claritin maker Schering-Plough Corp., under pressure from generic competition because the drug soon loses patent protection, last month changed tactics. Schering filed an FDA application to switch Claritin voluntarily to nonprescription, not only for nasal allergies but for hives as well.
So Monday, the FDA went back to its advisers to ask if patients could correctly self-diagnose run-of-the-mill hives instead of a more serious rash, and if so, whether Claritin constituted an appropriate nonprescription treatment for that, too.
The advisers said for chronic hives, that answer is yes. They urged some more studies for acute hives, an FDA spokeswoman said.
The FDA isn't bound by its advisers' recommendations but typically follows them.
Advisers to the Food and Drug Administration voted Monday that enough evidence exists that Claritin can treat chronic hives without a sufferer needing a prescription.
FDA's advisers last year ruled that Claritin and two competing products Pfizer's Zyrtec and Aventis' Allegra should be sold as over-the-counter allergy relievers. The FDA has said it agrees with that advice but has issued no ruling.
All three companies originally had resisted the switch. But Claritin maker Schering-Plough Corp., under pressure from generic competition because the drug soon loses patent protection, last month changed tactics. Schering filed an FDA application to switch Claritin voluntarily to nonprescription, not only for nasal allergies but for hives as well.
So Monday, the FDA went back to its advisers to ask if patients could correctly self-diagnose run-of-the-mill hives instead of a more serious rash, and if so, whether Claritin constituted an appropriate nonprescription treatment for that, too.
The advisers said for chronic hives, that answer is yes. They urged some more studies for acute hives, an FDA spokeswoman said.
The FDA isn't bound by its advisers' recommendations but typically follows them.
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