Dimetapp,Food and Drug Administration

1-17 of 38 results

Covidien says FDA extends Exalgo review

AP News 6 days ago

Covidien says FDA extends review on pain drug Exalgo to Feb. 22 Health care company Covidien PLC said Friday the Food and Drug Administration will take longer than expected to review the potential opioid pain drug Exalgo. The agency said it is ...

Dendreon's Provenge gets FDA review date

AP News 6 days ago

Dendreon's potential prostate cancer treatment Provenge gets May 1 FDA review date Biotechnology company Dendreon Corp. said Friday the Food and Drug Administration will make a regulatory decision on the potential prostate cancer vaccine Provenge by May 1. The drug is aimed ...

US company could make flu vaccine abroad after snub

AFP American Edition 6 days ago

A US company said it would consider making its innovative flu vaccine abroad after a panel of experts advising the US drug regulator voted not to recommend it for approval. A panel of 11 experts who sit on the Vaccines and Related ...

US company could make swine flu vaccine abroad after snub

AFP American Edition 6 days ago

A US company said it would make its flu vaccine abroad after a panel of experts Thursday gave the innovative product poor marks and failed to recommend it for approval by the US drug regulator. "Other countries -- Australia, for example, and ...

FDA: Plavix and Prilosec Don't Mix

consumeraffairs.com 6 days ago

Patients urged to avoid use with Prilosec/Prilosec OTC Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), according to a warning from the Food and Drug Administration (FDA). New data suggest that when patients ...

FDA panel backs safety, benefits of Spiriva

AP News 7 days ago

FDA panel backs stronger benefit claims and safety profile for inhaler drug Spiriva Federal health experts on Thursday brushed off lingering safety questions about a popular inhaler drug and suggested it carry bolder benefit claims. The Food and Drug Administration's panel of ...

FDA panel votes against new bug-based flu vaccine

Reuters US Online Report Health News 7 days ago

BETHESDA, Maryland (Reuters) - More safety data would be needed before a new type of influenza vaccine made in insect cells should get approval, federal advisers said on Thursday. A divided committee advising the U.S. Food and Drug Administration said the new ...

FDA issues warnings to Web sites over drug sales

AP News 7 days ago

FDA issues warning letters to 22 Web sites, alleges illegal sales of medical products The Food and Drug Administration said Thursday it issued 22 warning letters to Web site operators over alleged illegal sales of unapproved or misbranded drugs. The agency said ...

FDA panel backs stronger benefits of Spiriva

AP News 7 days ago

FDA panel backs stronger benefit claims for inhaler drug Spiriva marketed by Pfizer Federal health experts say an inhaler drug from a German drugmaker works well enough to carry bolder claims about reducing coughing, wheezing and other respiratory problems. The Food and ...

Company seeks to test stem cells for blindness

Reuters US Online Report Health News 7 days ago

WASHINGTON (Reuters) - Advanced Cell Technology, a small Massachusetts-based biotechnology company, said on Thursday it has asked for approval to test human embryonic stem cells in treating a rare cause of blindness. The company said it filed an IND, an investigational new ...

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