FDA Allows Two New Cigarettes to Hit Market

It's first such action since agency was given regulatory control over tobacco in 2009

By Steven Reinberg

HealthDay Reporter

TUESDAY, June 25 (HealthDay News) -- Using its newfound authority to regulate tobacco, the U.S. Food and Drug Administration has for the first time allowed two new cigarette brands to hit the market.

The agency also rejected requests to allow the marketing of four other new tobacco products it did not name.

The FDA first gained regulatory purview over tobacco products in 2009 under the Family Smoking Prevention and Tobacco Control Act. Therefore, "new tobacco products under FDA's authority cannot come to market without FDA's review," FDA commissioner Dr. Margaret Hamburg explained during an afternoon news conference Tuesday.

The cigarettes the FDA allowed are both Lorillard Tobacco Co. products -- Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box.

Because these products are essentially "equivalent" to approved products already being marketed, they "do not raise new questions of public health" and can be sold to U.S. consumers, explained Mitchell Zeller, director of FDA's Center for Tobacco Products.

He stressed that allowing the sale of these cigarettes does not mean that they are safer or less harmful than cigarettes already on the market.

"An FDA product order is not a finding by the FDA that the product is considered safe or safer than its predicate product, or less harmful in general," he said. "In addition, the companies cannot say their products are 'FDA-approved.'"

The agency rejected four new tobacco products because they determined that they were not similar enough to existing products already on the market.

"The applicant [also] did not adequately show that the new product did not raise new questions of public health," Zeller said at the news briefing.

By law, the FDA cannot release the names of the manufacturers of the rejected products or what types of products they were, he added.

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FDA Allows Return of Drug for Morning Sickness

Safety issues resolved, experts say Diclegis' return is long overdue

By Margaret Farley Steele

HealthDay Reporter

TUESDAY, April 9 (HealthDay News) -- A morning-sickness medication that was withdrawn from the market 30 years ago has won U.S. Food and Drug Administration approval under a new name.

In its new form, the drug -- formerly called Bendectin and now renamed Diclegis -- is the only medication specifically approved to treat the stomach upset many women suffer from during pregnancy.

In the intervening decades between the drug's withdrawal from the market and its re-approval on Tuesday, the medicine has undergone rigorous scrutiny and is now deemed safe by the FDA.

Obstetricians welcomed the announcement.

"The nausea and vomiting of early pregnancy can range from mild to debilitating," said Dr. Jennifer Wu, an obstetrician-gynecologist at Lenox Hill Hospital in New York City. "Patients will welcome more options for treatment with the reintroduction of Bendectin."

Their nausea may not disappear completely, but "it will hopefully decrease to the point that a patient can function," she added.

Diclegis, which combines vitamin B6 and the antihistamine doxylamine, is a delayed-release pill that's meant to be taken daily before symptoms set in. Those symptoms are often worse after waking up, hence the name "morning sickness." But some women are plagued by nausea all day long.

The medication is intended for women whose nausea isn't "adequately managed through recommended changes in diet and lifestyle," Dr. Hylton Joffe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.

Morning sickness usually improves after the first trimester. Recommended dietary and lifestyle changes to help beat the nausea include eating several small meals instead of three large meals, eating low-fat bland foods that are easy to digest and avoiding smells that can trigger episodes.

Another expert said the drug's reintroduction was long overdue.

"This drug should have never been taken off the market in the first place," said Dr. Keith Eddelman, director of obstetrics at Mount Sinai Medical Center in New York City. "It is not a controversial drug and the data is very convincing."

Another drug, Zofran, which is approved for nausea in cancer patients, is widely used for pregnancy, Eddelman said. "I think both of these medications are similar in safety," he added.

Bendectin was widely prescribed after its introduction in 1956, but costly lawsuits claiming safety issues caused the drug's maker, Merrell Dow, to pull it from the market in 1983.

Since then the drug has gone through rigorous testing. For this new approval, the FDA studied Diclegis in 261 women experiencing morning-sickness symptoms related to pregnancy. The women were between seven and 14 weeks of pregnancy and were randomly assigned to receive two weeks of treatment with Diclegis or a placebo, the FDA said.

The researchers found that women taking Diclegis experienced greater symptom relief than those taking placebo and missed fewer days of work.

In other studies, the combination of active ingredients in Diclegis were not found to pose an increased risk of danger to the fetus, the FDA said. However, side effects can include severe drowsiness or sleepiness.

Diclegis is marketed by the Quebec-based firm Duchesnay Inc. The company sells a generic version of the pill in Canada under the name Diclectin. U.S. sales of Diclegis are expected to start in June.

Duchesnay has not yet released a price for Diclegis, the Associated Press reported.

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