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Merck Updates Vaqta Supply Availability

[ Price : $8.95]

Merck reports that Vaqta vaccine for pediatric/adolescent use will be available for order beginning 12/1/08.

Merck PedvaxHiB and Comvax Shortage Continues

[ Price : $8.95]

FDA reports that an ongoing shortage involving Mercks PedvaxHiB and Comvax vaccines will not be resolved until mid-2009.

Quick Action Not Expected on Biosimilars Bill

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Sen. Kennedys spokesperson says that no immediate action is planned on his bill for a biosimilars pathway.

CLOSED FOR THANKSGIVING

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FDA Webviews News Room is closed for the U.S. Thanksgiving Day holidays. We will reopen on Monday, December 1.

Firm Recalls Dietary Supplement with Bumetanide

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Balanced Health Products recalls its StarCaps dietary supplement capsules due to the presence of an undeclared drug ingredient, bu...

DDMAC Faults Actelion for Tracleer Claims

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DDMAC warns Actelion that a flash card for its Tracleer contains unsubstantiated superiority claims and omits very important risk ...

Direct Mailers Omit, Minimize Cedax Risks

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DDMAC warns Shinogi USA over claims in two direct mailers that minimize risks and expand the indication of its Cedax.

FDA Clears EastMed Bladder-Support Device

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FDA clears an EastMed 510(k) for its Uresta Continence Care product, intended for use in treating women stress urinary incontinenc...

Voraxaze Web Page Promotes Drug Before Approval

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CDER sends an untitled letter to Protherics over its Web page promoting Voraxaze before it has been approved by FDA.

Quality Problems in Chinese Device Facility

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CDRH warns Onbo Electronics of multiple quality violations in its Shenzhen, China, medical device manufacturing facility.