The Food and Drug Administration has agreed to give a priority review to Salix Pharmaceutical's potential treatment for HIV-associated diarrhea.

The Raleigh company announced this morning that the FDA has set a June 5 target for making its decision on whether or not to approve the drug.

The FDA grants priority reviews to drugs that offer major advances in treatment or which provide treatment where no adequate therapy exists.

Salix submitted the drug, crofelemer, to the FDA for review in December.  Crofelemer are 125 mg tablets used to treat diarrhea in patients with HIV or AIDS who are on anti-retroviral therapy.

Salix estimates that some 150,000 patients on the therapy experience chronic diarrhea which can cause weight loss and complicate treatment.

Salix Pharmaceuticals CEO Carolyn Logan said today that the company won't comment on its recent meeting with federal regulators until it releases its second quarter earnings in August.

Logan, speaking at a Wells Fargo health care conference in Boston, said the company wants to wait until it gets the final minutes from the meeting.

"So we are hopeful that on August 8th we'll be able to give you our thoughts around that meeting, and of course if anything is finalized prior to that, we will press release it," she said.

Salix officials met Monday with Food and Drug Administration officials about the agency's decision to delay approval of the company's drug Xifaxan for treatment of irritable bowel syndrome.

In February, Salix received a Complete Response Letter from the FDA regarding its IBS application, which would be worth billions to the company. That's what the agency issues when its review process is complete and a drug application is not ready for approval.

The delay could mean the FDA will request a long-term study of the drug that could take several years to complete.

Salix officials believe such a study is not necessary.

U.S. Marshals have seized an estimated $16.5 million worth of a prescription drug that is manufactured by the Chapel Hill company Deston Therapeutics.

The supplies were taken from a Kentucky warehouse where the drug Auralgan Otic Solution was being stored.

Auralgan is used to treat pain and inflammation associated with ear infections.

The seizures were made Wednesday at the behest of the U.S. Food and Drug Administration, which said Deston’s sale of the product in the U.S. violates federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.

In two major healthcare rulings today, European medical authorities suspended GlaxoSmithKline's Avandia while U.S. regulators said they will require stricter safety warnings for the diabetes drug that's packaged in Wake County.

The European Medicines Agency said Avandia will be phased out in Europe over the next several months and patients will need to find alternative treatments.

In this country, the Food and Drug Administration will require additional safety labels and restrictions on Avandia's use. The FDA adopted the July recommendation of a federal advisory panel, whose 33 members were deeply divided on the issue of the drug's safety.

Health authorities in Europe and the United States cited concerns about the increased risk of heart attack and stroke from using Avandia, once the world's leading diabetes medication that reaped $3 billion for London-based GSK in 2006.

GlaxoSmithKline and Valeant Pharmaceuticals will have to wait a few more months for U.S. regulators to review their epilepsy drug.

The companies announced this morning that the Food and Drug Administration has extended the target date for reviewing the drug from Aug. 30 to Nov. 30.

The drug in question is ezogabine, which would be used to treat epilepsy in adults with partial onset seizures. It is designed to be used in conjunction with other drugs.

The FDA needed more time for the review because it only recently received the companies risk evaluation of the drug, according to a statement from the companies.

GSK, which maintains its U.S. headquarters in Research Triangle Park, and California-based Valeant, submitted a new drug application for ezogabine on Oct. 30, 2009.

Valeant has a small presence in the Triangle but has had discussions about signing on to Diamond View III, the third and final office building planned just beyond the walls of the Durham Bulls Athletic Park.

Valeant announced in June that it is merging with Biovail, Canada's largest publicly traded drug maker.

The merged company's headquarters will be in Toronto.

Pfizer will pay a record $2.3 billion penalty to settle an investigation into illegal prescription drug promotions.

The settlement with the Justice Department announced this morning includes a $1.2 billion criminal fine, the largest in U.S. history.

The case involves Pfizer's promotion of the painkiller Bexra and other medicines. Authorities said Pfizer's sales representatives created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

The world's largest company wined and dined doctors and sent them on exotic trips to induce them to prescribe its drugs including the impotence treatment Viagra and cholesterol medicine Lipitor, they said.

The overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules.

Of the civil penalty, $977,444 will go to North Carolina to resolve allegations that it improperly marketed the antipsychotic drug Geodon, Attorney General Roy Cooper said.