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FDA Approvals - Teva Receives FDA Approval for Generic Zoloft(R) Tablets (Business Wire


Teva Receives FDA Approval for Generic Zoloft(R) Tablets (Business Wire via Yahoo! Finance)
JERUSALEM----June 30, 2006--Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application to market its generic version of Pfizer's Zoloft Tablets, 25 mg, 50 mg, and 100 mg.

Oscient Pharmaceuticals Announces Meeting Date for FDA Advisory Committee to Address sNDA for Five-Day Treatment of (Business Wire via Yahoo! Finance)
WALTHAM, Mass.----June 28, 2006--The U.S. Food and Drug Administration has informed Oscient Pharmaceuticals Corporation that the FDA's Anti-Infective Drugs Advisory Committee will review the supplemental New Drug Application for FACTIVE tablets for the treatment of acute bacterial sinusitis on September 12, 2006.

FDA Approves the First Drug for Seasonal Depression Food and


FDA Approves the First Drug for Seasonal Depression
Food and Drug Administration approved Wellbutrin XL for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD)

FDA Approvals - Oscient Pharmaceuticals Announces Meeting Date for FDA Advisory Committee to


Oscient Pharmaceuticals Announces Meeting Date for FDA Advisory Committee to Address sNDA for Five-Day Treatment of (Business Wire via Yahoo! Finance)
WALTHAM, Mass.----June 28, 2006--The U.S. Food and Drug Administration has informed Oscient Pharmaceuticals Corporation that the FDA's Anti-Infective Drugs Advisory Committee will review the supplemental New Drug Application for FACTIVE tablets for the treatment of acute bacterial sinusitis on September 12, 2006.

FDA Grants Swift Approval to New Leukemia Drug (HealthDay via Yahoo! News)
THURSDAY, June 29 (HealthDay News) -- U.S. regulators gave accelerated approval Wednesday to a new targeted therapy to treat people with chronic myeloid leukemia (CML).

FDA issues fewer safety, quality citations (USA Today) The nation's


FDA issues fewer safety, quality citations (USA Today)
The nation's top food and drug regulator is citing fewer companies for poor quality or safety standards despite a relatively constant number of violations by companies, a congressional report says.

FDA Announces New Initiative To Modernize The Regulation Of Clinical Trials And Bioresearch Monitoring (BioresearchOnline)
The Food and Drug Administration (FDA) recently announced a series of new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency's approach to bioresearch monitoring as part of the Critical Path Initiative

FDA to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring (Kansas City InfoZine)
The Food and Drug Administration (FDA) announced a series of new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency's approach to bioresearch monitoring as part of the Critical Path Initiative.

FDA Approvals - Smith & Nephew and Q-MED Enter Into Strategic Alliance in


Smith & Nephew and Q-MED Enter Into Strategic Alliance in Osteoarthritis Treatment (FinanzNachrichten)
MEMPHIS, Tenn., and UPPSALA, Sweden, June 28 /PRNewswire-FirstCall/ -- Smith&Nephew ( Nachrichten ) Orthopaedics Trauma&Clinical Therapies and Q-MED AB ( Nachrichten ) today announced that they have formed a strategic alliance to develop and commercialize Q-MED's proprietary technology for the production of stabilized non-animal hyaluronic acid, NASHA (tm) for orthopedic uses.

ADVENTRX Initiates CoFactor Phase III Clinical Trial (FinanzNachrichten)
SAN DIEGO, June 28 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, ( Nachrichten ) Inc. today announced the initiation of its Phase III pivotal clinical trial for CoFactor(R) in metastatic colorectal cancer.

Medicis stock shows fatigue (East Valley Tribune)
Usually high-flying Medicis Pharmaceutical Corp. gave up nearly a third of its share value during the last few weeks.

ARCHITECT AUSAB Reagent Kit The ARCHITECT AUSAB is a lab


ARCHITECT AUSAB Reagent Kit
The ARCHITECT AUSAB is a lab test used to determine if a person is, or has been, infected with the hepatitis B virus (HBV), or to determine if a patient needs to be vaccinated with HBV vaccine. (Approved: 6/1/2006)

Jumbo Foods Recalls Smoked Turkey on Sourdough Triple Decker Sandwich


Jumbo Foods Recalls Smoked Turkey on Sourdough Triple Decker Sandwich Because of Possible Health Risk
The product was packaged in clear plastic with a label bearing its name, Smoked Turkey on Sourdough, 6.6oz, coded 051906 16D.

Agriculture Commissioner Tommy Irvin Warns Jamaican Tea Sample has Salmonella
Lab technicians at the Georgia Department of Agriculture confirmed Friday -- after consultation with the U.S. Food and Drug Administration -- that Caribbean Dreams Cerasee Tea has been found to be positive for salmonella.

FDA Licenses New Vaccine for Prevention of Cervical Cancer and


FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus
The Food and Drug Administration (FDA) today announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is approved for use in females 9-26 years of age.

FDA Approvals - Wyeth seeks approvals of two postmenopausal drugs (San Diego Union-Tribune)


Wyeth seeks approvals of two postmenopausal drugs (San Diego Union-Tribune)
NEW YORK Wyeth Monday said it has asked U.S. regulators to approve two new prescription drugs for postmenopausal women, one to prevent osteoporosis and the other to treat moderate to severe symptoms of menopause.

Lupin Receives Final Approval for Quinapril Tablets (RedNova)
BALTIMORE, June 26 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Quinapril Tablets USP in 5 mg, 10 mg, 20 mg and 40 mg strengths.

FDA issues fewer safety, quality citations (USA Today) The nation's


FDA issues fewer safety, quality citations (USA Today)
The nation's top food and drug regulator is citing fewer companies for poor quality or safety standards despite a relatively constant number of violations by companies, a congressional report says.

FDA Announces New Initiative To Modernize The Regulation Of Clinical Trials And Bioresearch Monitoring (Medical News Today)
The Food and Drug Administration (FDA) today announced a series of new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency's approach to bioresearch monitoring as part of the Critical Path Initiative. [click link for full article]

A Federal Blight for Cherry Farmers (BusinessWeek Online via Yahoo! UK & Ireland Finance)
The FDA's warning letters to cherry farmers about health claims posted on their Web sites have troubling legal implications

FDA Approvals - Lupin Receives Final Approval for Quinapril Tablets (RedNova) BALTIMORE, June


Lupin Receives Final Approval for Quinapril Tablets (RedNova)
BALTIMORE, June 26 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Quinapril Tablets USP in 5 mg, 10 mg, 20 mg and 40 mg strengths.

Endo Receives FDA Approval For Opana(R) ER (oxymorphone HCl) Extended-Release And Opana(R) (oxymorphone HCl) Immediate (Medical News Today)
Endo Pharmaceuticals Inc., awholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq:ENDP), today announced that the U.S. Food and Drug Administration (FDA) hasgranted final approval of the company's New Drug Applications (NDAs) forits extended- release and immediate-release formulations of oxymorphonehydrochloride. [click link for full article]

Bioheart, Inc. To Receive Funds From a Grant Awarded By the State of Ohio to Further Develop Adult Stem Cell Therapies (RedNova)
SUNRISE, Fla., June 26 /PRNewswire/ -- Bioheart, Inc. announced today that in conjunction with Cleveland Clinic it will receive funds from a grant awarded by the Biomedical Research and Commercialization Program (BRCP) of the State of Ohio.

New Online Course Offers Insight into the Importance of Sex


New Online Course Offers Insight into the Importance of Sex and Gender Differences in Human Health
The course offers participants a basic scientific understanding of the major physiological differences between the sexes, their influence on illness and health outcomes, and their implications for policy, medical research, and health care.

FDA Approvals - Ranbaxy Receives FDA Approval To Market Simvastatin 80mg Tablets With


Ranbaxy Receives FDA Approval To Market Simvastatin 80mg Tablets With 180-Day Exclusivity (Medical News Today)
Ranbaxy Pharmaceuticals Inc.(RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL),announced today that the company has received approval from the U.S. Foodand Drug Administration (FDA) to manufacture and market Simvastatin TabletsUSP, 80mg with 180-day exclusivity in the U.S. [click link for full article]

Teva Announces Novartis' Sandoz Unit Seeks to Delay First FDA Approval of Generic Zocor(R) (RedNova)
Teva Pharmaceutical Industries Ltd. (Nasdaq: TE

Ranbaxy Receives FDA Approval to Market Simvastatin 80mg Tablets With 180-Day Exclusivity (RedNova)
PRINCETON, N.J., June 23 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that the company has received approval from the U.S.

Endo Receives FDA Approval for Opana(R) ER (oxymorphone HCl) Extended-Release


Endo Receives FDA Approval for Opana(R) ER (oxymorphone HCl) Extended-Release and Opana(R) (oxymorphone HCl) Immediate (PR Newswire via Yahoo! Finance)
Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. , today announced that the U.S. Food and Drug Administration has granted final approval of the company's New Drug Applications for its extended- release and immediate-release formulations of oxymorphone hydrochloride.

HealthSonix Registers the AquaSonix Medical Device With FDA (RedNova)
HealthSonix Inc. ("HealthSonix" or the "Company") (PINKSHEETS: HSXI) (www.HealthSonix.com) is pleased to announce that it has registered the AquaSonix medical device with the United States Food and Drug Administration (FDA). Indications are for pain reduction and muscle relaxation.

Endo Receives FDA Approval For Opana(R) ER (oxymorphone HCl) Extended-Release And Opana(R) (oxymorphone HCl) Immediate (Medical News Today)
Endo Pharmaceuticals Inc., awholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq:ENDP), today announced that the U.S. Food and Drug Administration (FDA) hasgranted final approval of the company's New Drug Applications (NDAs) forits extended- release and immediate-release formulations of oxymorphonehydrochloride. [click link for full article]

AxSYM HBsAg Assay This device is a lab test used


AxSYM HBsAg Assay
This device is a lab test used to confirm whether or not a person is infected with hepatitis B virus (HBV). The reagents are used with the Abbott AxSYM Instrument System to identify certain virus proteins associated with HBV. If these virus proteins are (Approved: 6/1/2006)

Novartis Consumer Health Conducts Nationwide Voluntary Recall of Triaminic Vapor


Novartis Consumer Health Conducts Nationwide Voluntary Recall of Triaminic Vapor Patch Product in U.S.
Novartis Consumer Health announced today it is conducting a nationwide voluntary recall of all Vapor Patch product marketed under the Triaminic brand due to the serious adverse health effects that could result if the product is ingested by the child removing the patch and chewing on it.

R. L. Schreiber, Inc. Issues Allergy Alert on Undeclared Soy and Milk in Beef Gravy Mix, Bar Code 1270, Lot Code E04A1
The product comes in a 12 oz white plastic bag labeled R. L. Schreiber, Inc. Beef Gravy Mix Bar Code 1270 marked with lot code number "E04A1" on the package label.

HJ Baker and Bro., Inc. Announces National Recall of Three Animal Feed Products Containing Prohibited Ingredients
These products were distributed in bulk or bags to feed manufacturers and dairy farms in Georgia, Kentucky, Michigan, Florida, Alabama, Tennessee, Mississippi, California, and Louisiana.

FDA Approvals - Ranbaxy Receives FDA Approval to Market Simvastatin 80mg Tablets with


Ranbaxy Receives FDA Approval to Market Simvastatin 80mg Tablets with 180-Day Exclusivity (PR Newswire via Yahoo! Finance)
Ranbaxy Pharmaceuticals Inc. , a wholly owned subsidiary of Ranbaxy Laboratories Limited , announced today that the company has received approval from the U.S. Food and Drug Administration to manufacture and market Simvastatin Tablets USP, 80mg with 180-day exclusivity in the U.S.

Ranbaxy Receives FDA Approval to Market Simvastatin 80mg Tablets With 180-Day Exclusivity (RedNova)
PRINCETON, N.J., June 23 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that the company has received approval from the U.S.

FDA Approvals - Teva Announces Novartis' Sandoz Unit Seeks to Delay First FDA


Teva Announces Novartis' Sandoz Unit Seeks to Delay First FDA Approval of Generic Zocor(R) (RedNova)
Teva Pharmaceutical Industries Ltd. (Nasdaq: TE

Ranbaxy Receives FDA Approval To Market Simvastatin 80mg Tablets With 180-Day Exclusivity (Medical News Today)
Ranbaxy Pharmaceuticals Inc.(RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL),announced today that the company has received approval from the U.S. Foodand Drug Administration (FDA) to manufacture and market Simvastatin TabletsUSP, 80mg with 180-day exclusivity in the U.S. [click link for full article]

FDA Issues Guidance to Help Prevent Inadvertent Introduction of Allergens


FDA Issues Guidance to Help Prevent Inadvertent Introduction of Allergens or Toxins into the Food and Feed Supply
The guidance provides greater transparency by explaining how the agency will conduct its early safety evaluation of new proteins in new plant varieties, including bioengineered varieties, that are in development for possible use as food for humans or animals.

Endo Receives FDA Approval for Opana(R) ER (oxymorphone HCl) Extended-Release


Endo Receives FDA Approval for Opana(R) ER (oxymorphone HCl) Extended-Release and Opana(R) (oxymorphone HCl) Immediate (PR Newswire via Yahoo! Finance)
Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. , today announced that the U.S. Food and Drug Administration has granted final approval of the company's New Drug Applications for its extended- release and immediate-release formulations of oxymorphone hydrochloride.

Amazon Biotech Phase I/II HIV Clinical Trial Protocol Receives FDA "Green Light" (SYS-CON Media)
Amazon Biotech, Inc. (OTCBB: AMZBE) (FRANKFURT: B2D) announced today that it has successfully negotiated a phase I/IIprotocol with the FDA. This allows Amazon Biotech to move forward withimplementation of its filed Phase I/II trial of its proprietary AMZ0026therapy in HIV Positive patients.

Update: HealthSonix Registers AquaSonix Medical Device With the FDA (SYS-CON Media)
HealthSonix Inc. ('HealthSonix' or the 'Company')(PINKSHEETS: HSXI) www.HealthSonix.com, is pleased to announce that it hasregistered the AquaSonix medical device with the United States Food andDrug Administration (FDA). Indications are for pain reduction and musclerelaxation. The device was designated as class 1, the safest classificationfor medical devices.
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