Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Rivaroxaban (Centre Daily Times)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.

Ikaria(R) Receives FDA Orphan Drug Designation For Inhaled Carbon Monoxide For Delayed Graft Function In Solid Organ ... (Medical News Today)
Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and severity of delayed graft function (DGF) in patients undergoing solid organ transplantation. Ralf Rosskamp, M.D.

Osteotech's Plexur M(TM) Biocomposite Receives FDA Clearance In Spine (Medical News Today)
Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative healing, announced that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for Plexur M(TM) Biocomposite for use in spinal applications.

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FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.

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FDA Reaches Settlement with California Hearing Device Maker
The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law.

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Titan Pharmaceuticals Announces Positive Results From Phase III Clinical Trial Of Probuphine For The Treatment Of ... (Medical News Today)
Titan Pharmaceuticals, Inc. (AMEX:TTP) announced positive, statistically significant results from its randomized, double-blind, placebo controlled, multi-center Phase III clinical trial of Probuphine . Probuphine is Titan's novel, subcutaneous implant formulation designed using its ProNeura technology to deliver six months of buprenorphine.

UC Irvine Extension Offers Clinical Data Management (Centre Daily Times)
The University of California, Irvine Extension, announces a new course for clinical data management professionals, clinical research associates, project managers, and programmers who support the design and development of clinical databases. The new course, "Clinical Data Management," will be offered online from Oct. 6 to Nov. 16.

Noven Announces Final FDA Approval of Stavzor(TM) for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches (Business Wire via Yahoo! Finance)
MIAMI----Noven Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved Stavzor in 125 mg, 250 mg and 500 mg strengths. Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association ...

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Vanda Pharmaceuticals Announces Receipt Of Not Approvable Letter From FDA For Iloperidone (Medical News Today)
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.

Osteotech's Plexur M(TM) Biocomposite Receives FDA Clearance In Spine (Medical News Today)
Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative healing, announced that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for Plexur M(TM) Biocomposite for use in spinal applications.

NexMed Receives FDA Response For Erectile Dysfunction Product (Medical News Today)
NexMed, Inc. (Nasdaq: NEXM), announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.

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FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

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Schering-Plough Reports Financial Results for Second Quarter of 2008 (PR Newswire via Yahoo! Finance)
Schering-Plough Corporation today reported financial results for the second quarter of 2008.

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Endeavor® Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi Exchange II (MX2) Stent Delivery Systems
The Endeavor® Zotarolimus-Eluting Coronary Stent is a tiny, expandable, mesh-like tube made of a cobalt-based metal with a drug (called zotarolimus) contained within a thin polymer coating on its surface. The Stent is mounted over a deflated... (Approved: 2/1/2008)

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Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16)
The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide.

EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient
EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil.

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SemBioSys submits IND for safflower-produced insulin to U.S. FDA (CNW Group via Yahoo! Finance)
SemBioSys Genetics Inc. , a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced that it has submitted an Investigational New Drug application for safflower-produced recombinant human insulin to the United States Food and Drug Administration .

Vanda Pharmaceuticals Announces Receipt Of Not Approvable Letter From FDA For Iloperidone (Medical News Today)
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.

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FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.

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FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

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Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol To FDA For Comment (Medical News Today)
Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska") announced that it has submitted for comment a synopsis of a proposed Phase 3 clinical study for its lead drug, ATPace(TM), to the U.S. Food and Drug Administration's (the "FDA") Division of Cardiovascular and Renal Products.

Vanda Pharma Sinks on FDA Rejection (TheStreet.com)
Its lead drug, antipsychotic iloperidone, will require another clinical trial and more safety data before approval.

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Taro Updates Shareholders on Financial Turnaround; Projects Significant Growth in Net Sales in 2008; Reaffirms Board's ... (Centre Daily Times)
Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) today announced that it is sending a letter to its shareholders updating them on the status of the Company's financial and operational turnaround.

FDA Issues Not Approvable Letter for Iloperidone to Vanda Pharmaceuticals (Centre Daily Times)
Titan Pharmaceuticals, Inc. (AMEX:TTP) today announced that Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA) has received a not approvable letter for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia, from the U.S. Food and Drug Administration (FDA). Vanda, the sub-licensee for iloperidone, is responsible for the development and commercialization of this product.

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FDA To Recommend That Doctors Conduct Genetic Screening Before Prescribing Antiretroviral Abacavir To Reduce Allergic ... (Medical News Today)
FDA on Thursday is expected to issue an advisory that urges physicians to conduct genetic testing before prescribing GlaxoSmithKline's antiretroviral drug abacavir to reduce allergic reactions in people taking the drug, the New York Times reports. The recommendation to conduct genetic screenings will be included in a black box warning on the drug's label.

VEGFbTM Has Been Granted Orphan Drug Designation By The FDA For The Treatment Of Advanced Melanoma (Medical News Today)
PhiloGene, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to VEGFb for the treatment of patients with advanced melanoma. This approval is for a larger subset of melanoma patients than was requested, and includes melanoma in stages IIb through IV.

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FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency.

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Schering-Plough Reports Financial Results for Second Quarter of 2008 (PR Newswire via Yahoo! Finance)
Schering-Plough Corporation today reported financial results for the second quarter of 2008.

Earnings Preview: Schering-Plough (AP via Yahoo! Finance)
Schering-Plough Corp., a major drug and consumer health products maker, reports earnings for the second quarter on Monday morning. The following is a summary of key developments and analyst opinion related to the period.

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Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads
The Stratos LV (-T) Cardiac Resynchronization Therapy Pacemakers (CRT-P) are rate adaptive pulse generators that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure. (Approved: 5/12/2008)

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Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1)
Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10).

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FDA Reaches Settlement with California Hearing Device Maker
The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law.

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