FDA Issues Complete Response Letter For Ceftobiprole For Treatment Of Complicated Skin Infections (Medical News Today)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

Arthritis Advisory Committee Recommends FDA Approval Of Febuxostat For The Treatment Of Hyperuricemia In Patients With ... (Medical News Today)
Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout.

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FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid
The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.

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Women given alternatives to pill (BBC News)
Women are to be asked to try alternatives to the contraceptive pill under plans to cut unwanted pregnancies.

Read more about Women given alternatives to pill (BBC News) Women are to

T-SPOT.TB
T-Spot.TB is a laboratory test kit which contains reagents to detect the immune response of Thymus cells (T cells) found in an individual?s white blood cells that are stimulated by proteins produced by the bacteria that causes tuberculosis (TB). (Approved: 7/25/2008)

Read more about T-SPOT.TB T-Spot.TB is a laboratory test kit which contains reagents

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5)
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination
Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella.

Read more about FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November

FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid
The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.

Read more about FDA Acts to Avoid Shortage and Strengthen the Safety of

FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

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FDA seeks advice to improve tracking of produce (High Plains Journal)
WASHINGTON (AP) Prompted by this summer s salmonella outbreak, the government has begun investigating how to quickly identify the source of contaminated food and stop it from getting to consumers.

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FDA Issues Complete Response Letter For Ceftobiprole For Treatment Of Complicated Skin Infections (Medical News Today)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

PLC Systems Receives Full FDA Approval For Pivotal Study Of RenalGuard(TM) In The U.S. (Medical News Today)
PLC Systems Inc. (OTC Bulletin Board: PLCSF) announced that it has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of the Company's RenalGuard System(TM) and associated therapy in the prevention of Contrast-Induced Nephropathy (CIN).

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FDA Accepts Filing And Grants Priority Review For DX-88 For Hereditary Angioedema (Medical News Today)
Dyax Corp. (NASDAQ: DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review.

PLC Systems Receives Full FDA Approval For Pivotal Study Of RenalGuard(TM) In The U.S. (Medical News Today)
PLC Systems Inc. (OTC Bulletin Board: PLCSF) announced that it has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of the Company's RenalGuard System(TM) and associated therapy in the prevention of Contrast-Induced Nephropathy (CIN).

FDA Approves New Drug To Alleviate Moderate To Severe Pain (Medical News Today)
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.

Read more about FDA Approvals - FDA Accepts Filing And Grants Priority Review For DX-88 For

FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration
The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials.

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FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

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CIMTEK's Enhanced Magellon Software Eases FDA Compliance (PharmaceuticalOnline)
CIMTEK, has announced an upgrade to its Magellon Quality Lifecycle Management software -- giving medical device-makers a streamlined way to rapidly deliver quality products and maintain compliance with the Food and Drug Administration's Title 21 Code of Federal Regulations Part 11.

Read more about CIMTEK's Enhanced Magellon Software Eases FDA Compliance (PharmaceuticalOnline) CIMTEK, has

FDA To Share Perspective On Polymorphic Forms In Abbreviated New Drug Applications - 6th Annual IQPC Polymorphism & ... (Medical News Today)
The FDA have confirmed they will be providing an insight into Polymorphic Forms in Abbreviated New Drug Applications (ANDAs). Andre Raw, Ph.

FDA Accepts Filing And Grants Priority Review For DX-88 For Hereditary Angioedema (Medical News Today)
Dyax Corp. (NASDAQ: DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review.

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FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

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Women given alternatives to pill (BBC News)
Women are to be asked to try alternatives to the contraceptive pill under plans to cut unwanted pregnancies.

Read more about Women given alternatives to pill (BBC News) Women are to

EVOLENCE Collagen Filler
Evolence Collagen Filler is a sterile, injectable, biodegradable, yellowish, opaque gel that is injected into the inner layers of facial skin (mid to deep dermis) in order to correct moderate to deep facial wrinkles and folds such as those around the... (Approved: 6/27/2008)

Read more about EVOLENCE Collagen Filler Evolence Collagen Filler is a sterile, injectable,

Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3)
Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat.

Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination
Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella.

Read more about Nestle Withdraws Nestle Farinha Lactea Cereal in the United States

FDA To Share Perspective On Polymorphic Forms In Abbreviated New Drug Applications - 6th Annual IQPC Polymorphism & ... (Medical News Today)
The FDA have confirmed they will be providing an insight into Polymorphic Forms in Abbreviated New Drug Applications (ANDAs). Andre Raw, Ph.

FDA Approves New Drug To Alleviate Moderate To Severe Pain (Medical News Today)
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.

Read more about FDA Approvals - FDA To Share Perspective On Polymorphic Forms In Abbreviated New

HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief
Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.

Read more about HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as