FDA unapproved-drug campaign bites Lundbeck

A recent addition to the FDA list of drugs to be discontinued is Lundbeck's Mebaral (mephobarbital) 32-, 50- and 100-mg tablets. The drug, first approved for U.S. use in 1935, is a barbiturate used to treat anxiety and prevent seizures.

In this case, the cause isn't a lack of raw materials, reliable API suppliers or profitability--reasons often cited by drugmakers for supply shortages and decisions to quit making a product. Rather, Lundbeck is abandoning the product because it would have to file and gain approval for a Mebaral new drug application to comply with FDA regulations.

The company says in a statement that it lacks the documentation required to substantiate continued grandfather status as a product approved prior to the Federal Food, Drug and Cosmetic Act of 1938.

"After careful consideration, given other potential alternative therapies currently available for this patient population, Lundbeck determined that pursuing an NDA for Mebaral is not a viable option," the statement says. It expects supply to be depleted by end of year.

Lundbeck is not the only manufacturer of a pre-act drug to be ensnared by the FDA's ongoing effort to require makers of unapproved drugs to gain formal agency approval. Cody Labs suffered a similar fate last summer with its morphine sulfate oral solution. The company initially tried to fight the action, but Cody parent Lannett announced earlier this month that its NDA for the drug is progressing with the FDA, and that a pre-approval inspection of the manufacturing facility is the next step.

- here's the FDA discontinued drugs listing
- see the Lannett release
- and here's the FDA unapproved drugs page

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