Allergan Inc. challenges Government’s Ban on marketing unapproved uses
Botox maker Allergan

Botox maker Allergan seeks to remove the ban on marketing off-label uses for pharmaceuticals.

The Irvin Company argued in a lawsuit filed recently that it should have the permission to give information to doctors about the correct usage of Botox for treatments that are not approved by the Food and Drug Administration, including bladder problems, muscle spasms and headaches.

Botox has been approved by the FDA for cosmetic use as a wrinkle treatment and is also used for eye-muscle disorders, excessive underarm sweating and cervical dystonia in adults, causing abnormal head positions and neck pain.

It is illegal for companies to promote doctors to use medications in certain ways which are not approved by the FDA, though doctors can legally prescribe drugs for unapproved uses.

Caroline Van Hove, a spokesman of Allergan, put across its view on this matter and said that it should be allowed to supply enough information to the physicians with information on risks, benefits, dosage levels, limitations and which patients to be treated in off-label uses.

The company has worked on compiling information about the off-label uses of Botox, which also includes the safety and issues and benefits and would like to provide it to doctors.

"We don't want to promote off-label use, but we need to make sure physicians are using our products in the safest way possible," Hove said.

Allergan in therefore hoping that the FDA will formulate regulations which require drug makers to inform doctors about off-label uses while encouraging physicians to participate in clinical trials that will lead off-label uses into government approval.

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