The drug will be used for the treatment of leprosy and is expected to be issued to 50 patients per year.

BBC Washington correspondent Paul Reynolds: "Black market"

Thalidomide, originally used as a sedative for pregnant women, was banned worldwide more than 30 years ago after it caused horrific defects in thousands of babies.

Severe restrictions will be put on the drug's use, and patients will be expected to follow a strict birth control regime while using it.

But the BBC's Washington correspondent says there are fears that the drug will reach a wider population. It has already appeared on the black market in Mexico.

Strict conditions

The US Food and Drug Administration approved the drug's sale for use in treating erythema nodosum leprosum, a painful, debilitating condition.

An FDA statement said: "Because of its well-known potential for causing birth defects, thalidomide will be among the most tightly restricted drugs ever to be marketed in the United States."

A 'thalidomide baby' with prosthetic arms

Thalidomide manufacturer, the Celgene Corporation, said precautions are in place to ensure the drug is not taken by pregnant women.

Female patients will be required to use two forms of birth control while taking the drug and have regular pregnancy tests.

Men using the drug will be required to use condoms during sex.

Before a prescription is issued, a copy of an informed consent form must be presented at the pharmacy. Prescriptions will be for 28 days, with no automatic renewals.

Celgene began developing the drug for Aids-related, dermatological and cancer-related conditions in 1992.

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