FDA Approves Xiaflex for Debilitating Hand Condition The U.S. Food

FDA Approves Xiaflex for Debilitating Hand Condition
The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person s ability to straighten and properly use their fingers.

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Phenylpropanolamine Health Advisory - On December 22, 2005 the FDA issued a notice of proposed rulemaking for over-the-counter (OTC) nasal decongestant and weight control products containing phenylpropanoloamine preparations. This proposed rule reclassifies phenylpropanolamine as nonmonograph not generally recognized as safe and effective. Written and electronic comments and new data can be submitted by March, 22, 2006.

The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. In addition, FDA has issued a public health advisory concerning phenylpropanolamine. This drug is an ingredient that was used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.

The FDA recommends that consumers read the labels of OTC drug products to determine if the product contains PPA. The Agency believes this to be the most accurate method for determining the PPA content of OTC products rather than providing an incomplete or out-of-date list of products that may have already been reformulated and no longer contain PPA.

FDA’s Nonprescription Drugs Advisory Committee recently discussed this Yale study along with additional information on phenylpropanolamine. The Advisory Committee determined that there is an association between PPA and hemorrhagic stroke. It recommended that PPA be considered not safe for over-the-counter use.

Click on this link for a PDF about Phenylpropanolamine:
Phenylpropanolamine PDF

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B. Braun Anticipates Becoming First To Deliver FDA Approved 2g Cefazolin (Medical News Today)
B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, said today it anticipates U.S. Food and Drug Administration (FDA) approval for 2g Cefazolin for Injection USP and Dextrose Injection USP in B. Braun's DUPLEX(R) Drug Delivery System. The FDA approval will make B.

Advanced Life Sciences Announces Outcome Of FDA's Anti-Infective Drugs Advisory Committee Review Of Restanza(TM) ... (Medical News Today)
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) announced that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza(TM) (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP) (11 positive, 3 negative, 1 abstaining).

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FDA Warns Consumers about Counterfeit Alli
The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)?the maker of the FDA approved over-the-counter weight-loss product? revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

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FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients
The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.

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