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Recent news from the US Food and Drug Administration.
Click "read more" links to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom.
FDA
Approves New Drug to Alleviate Moderate to Severe Pain (November 24)
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride,
an immediate-release oral tablet for the relief of moderate to severe
acute pain. [ Read
more ]
FDA
Acts to Avoid Shortage and Strengthen the Safety of Sucraid (November
20)
The U.S. Food and Drug Administration today issued an expedited approval
of a supplemental application that allows for changes in the manufacturing
of Sucraid (sacrosidase) Oral Solution. The approval will prevent a product
shortage by allowing the sole manufacturer of the drug, QOL Medical, to
obtain Sucraid's active ingredient from a different manufacturer. [ Read
more ]
FDA
Approves New Drug to Treat Severe Form of Epilepsy (November 20)
The U.S. Food and Drug Administration has approved a new drug, Banzel
(rufinamide), for use as an adjunctive (add-on) treatment for seizures
associated with Lennox-Gastaut syndrome. [ Read
more ]
FDA
Warns Public of Extortion Scam by FDA Impersonators (November 12)
The U.S. Food and Drug Administration is warning consumers about a fraudulent
scheme to extort money from consumers by callers who falsely identify
themselves as "FDA special agents" or other FDA officials. [
Read
more ]
FDA
Seizes Contaminated Heparin from a Cincinnati Manufacturer (November 6)
As part of the U.S. Food and Drug Administration's ongoing efforts to
ensure that heparin for patients remains safe, the government today seized
11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.
[ Read
more ]
FDA
Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November
5)
The U.S. Food and Drug Administration is notifying health care professionals
and patients that Tyco Healthcare Group LP (Covidien) is recalling one
lot of ReliOn sterile, single-use, disposable, hypodermic syringes with
permanently affixed hypodermic needles due to possible mislabeling. The
use of these syringes may lead to patients receiving an overdose of as
much as 2.5 times the intended dose, which may lead to hypoglycemia, serious
health consequences, and even death. [ Read
more ]
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