FDA Approvals-New Drugs, Diagnostics and Devices

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HIV: FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue

Date: 12/31/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01936.html

Prostate Cancer: FDA Approves Drug for Patients with Advanced Prostate Cancer

These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.

Date: 12/29/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01935.html

Blood Flow: FDA Approves First Imaging Agent to Enhance Scans of Blood Flow

Helps detect possible blood vessel problems

Date: 12/24/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01934.html

Gastrointestinal Cancer: FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

GIST is a fairly rare form of cancer that originates in cells found in the wall of the GI tract...

Date: 12/19/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01931.html

Bone Marrow Transplants: FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants

Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas...

Date: 12/18/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01929.html

Pain: FDA Approves New Drug to Alleviate Moderate to Severe Pain

Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.

Date: 11/26/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01916.html

Bladder: FDA Approves Toviaz, a New Drug to Treat Overactive Bladder

...works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency...

Date: 10/31/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01910.html

AIDS: HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief

Date: 10/29/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01909.html

Lung Valve: FDA Approves Lung Valve to Control Some Air Leaks after Surgery

...approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery.

Date: 10/27/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01906.html

Enlarged Prostate Gland: FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland

...approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

Date: 10/10/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01902.html

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