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  • Bridge Labs China Study Accepted FDA

    September 8, 2008
    The FDA has accepted data submitted from Bridge Laboratories' Beijing facility on behalf of a U.S. biotech client. The GLP nonhuman primate toxicology study data was generated and submitted as part of an IND package to the FDA. Bridge’s Beijing…

  • FDA Approves Amgen's Nplate

    August 25, 2008
    The FDA has approved Amgen's Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA…

  • FDA Approves Amgen's Nplate

    August 25, 2008
    The FDA has approved Amgen's Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA…

  • FDA Delays Centocor's BLA for Psoriasis Drug

    August 8, 2008
    Centocor's BLA for ustekinumab for the treatment of plaque psoriasis has been delayed by three months to December 2008. Centocor filed the BLA late in 2007.     The FDA extended the review period in order to review amendments to the…

  • FDA Delays Centocor's BLA for Psoriasis Drug

    August 8, 2008
    Centocor's BLA for ustekinumab for the treatment of plaque psoriasis has been delayed by three months to December 2008. Centocor filed the BLA late in 2007.     The FDA extended the review period in order to review amendments to the…

  • FDA Grants Pediatric Exclusivity for Topamax

    July 25, 2008
    Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., itself a division of Johnson & Johnson, received approval from the FDA for pediatric exclusivity for Topamax for use in patients aged 1 to 24 months with partial…

  • FDA Grants Pediatric Exclusivity for Topamax

    July 25, 2008
    Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., itself a division of Johnson & Johnson, received approval from the FDA for pediatric exclusivity for Topamax for use in patients aged 1 to 24 months with partial…

  • Synomics Successfully Completes FDA Audit

    July 18, 2008
    The FDA has completed an inspection of Synomics Pharmaceutical Services' facilities and operations in Wareham, MA. The inspection included both PAI and general regulatory compliance, as Synomics Pharma had been named in three NDAs. No 483's were issu…

  • HollisterStier Gets MHRA and FDA Certifications for New Filling Line

    July 17, 2008
    HollisterStier Contract Manufacturing received its certificate of GMP compliance by the Medicines and Healthcare Products Regulatory Agency (MHRA). This certification was issued following an inspection of the company's facilities, quality systems and…

  • GSK Responds to FDA Inquiry for Cervarix

    June 30, 2008
    GlaxoSmithKline has submitted its response to questions raised by the FDA regarding its application for approval of Cervarix, its vaccine to prevent cervical cancer.     GSK will also submit Phase III efficacy study data from HPV-00…

  • GSK Responds to FDA Inquiry for Cervarix

    June 30, 2008
    GlaxoSmithKline has submitted its response to questions raised by the FDA regarding its application for approval of Cervarix, its vaccine to prevent cervical cancer.     GSK will also submit Phase III efficacy study data from HPV-00…

  • FDA Extends Prasugrel Review

    June 24, 2008
    The FDA has extended by three months its review of the NDA for Effient, which was previously known by its generic name of prasugrel. The drug's application was accepted in February 2008 and its deadline for action was this week. The new action date i…

  • FDA Extends Prasugrel Review

    June 24, 2008
    The FDA has extended by three months its review of the NDA for Effient, which was previously known by its generic name of prasugrel. The drug's application was accepted in February 2008 and its deadline for action was this week. The new action date i…

  • FDA Approves Seroquel for Bipolar Maintenance

    May 14, 2008
    AstraZeneca received approval from the FDA for Seroquel for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex. Seroquel is approved by the FDA for the treatment of schizophrenia, and both depre…

  • FDA Approves Seroquel for Bipolar Maintenance

    May 14, 2008
    AstraZeneca received approval from the FDA for Seroquel for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex. Seroquel is approved by the FDA for the treatment of schizophrenia, and both depre…

  • Strattera FDA-Approved for ADHD Maintenance


    May 8, 2008
    Eli Lilly and Co. received approval from the FDA for Strattera for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approv…

  • Strattera FDA-Approved for ADHD Maintenance


    May 8, 2008
    Eli Lilly and Co. received approval from the FDA for Strattera for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approv…

  • FDA Proposes Change To CBE Supplement Rule

    Gary C. Messplay, J.D. || April 30, 2008
    Proposed rule to codify long-standing policy stirs debate

  • GSK, Pozen Gain FDA Approval for Migraine Drug

    April 16, 2008
    GlaxoSmithKline and Pozen, Inc. received FDA approval of Treximet for the treatment of migraine attacks in adults. Treximet is the first migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of GSK's migr…

  • GSK, Pozen Gain FDA Approval for Migraine Drug

    April 16, 2008
    GlaxoSmithKline and Pozen, Inc. received FDA approval of Treximet for the treatment of migraine attacks in adults. Treximet is the first migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of GSK's migr…

  • FDA Approves GSK's Rotarix Vaccine

    April 4, 2008
    GlaxoSmithKline received approval from the FDA for its Rotarix vaccine for the prevention of rotavirus gastroenteritis in infants. With two doses, Rotarix offers protection against the most common rotavirus types in the U.S. and allows infants to com…

  • FDA Approves GSK's Rotarix Vaccine

    April 4, 2008
    GlaxoSmithKline received approval from the FDA for its Rotarix vaccine for the prevention of rotavirus gastroenteritis in infants. With two doses, Rotarix offers protection against the most common rotavirus types in the U.S. and allows infants to com…

  • FDA Launches Drug Safety Effort

    February 27, 2008
    The FDA is launching a new effort for post-approval drug safety, called "Safety First," meant to strengthen its supervision of prescription drugs after approval.     The plan, first reported by the Wall Street Journal and…

  • Vetter Gets Production Approval from FDA

    February 27, 2008
    Vetter Pharma-Fertigung GmbH & Co. has been granted approval by the FDA for the production of a client's new drug. The company will begin filling the drug at its Ravensburg Vetter South (RVS) facility. Vetter provides contract manufacturing servi…

  • FDA Approves Abbott's Cholesterol Combo Drug

    February 19, 2008
    Abbott received approval from the FDA for Simcor, the first fixed-dose combination of cholesterol therapies, Niaspan (Abbott's niacin extended-release) and simvastatin. Simcor is approved for use along with diet to lower levels of elevated total chol…

  • FDA Approves Abbott's Cholesterol Combo Drug

    February 19, 2008
    Abbott received approval from the FDA for Simcor, the first fixed-dose combination of cholesterol therapies, Niaspan (Abbott's niacin extended-release) and simvastatin. Simcor is approved for use along with diet to lower levels of elevated total chol…

  • Akorn Passes FDA Lyo-PAI/cGMP Inspection

    December 21, 2007
    Akorn, Inc. has received a satisfactory inspection from the FDA as part of a pre-approval inspection of the company's lyophilization facilities in Decatur, IL. Akorn had cGMP issues in the past, but the recent inspection led the Chicago office of CDE…

  • Neurocrine Restructures After FDA Letter

    December 14, 2007
    Neurocrine Biosciences announced that it will lay off approximately 130 employees at its San Diego campus, as a part of its restructuring program to prioritize its R&D programs and associated costs and expenses after an FDA delay on insomnia trea…

  • FDA inspects Hovione TTC in NJ

    November 2, 2007
    Hovione's Technology Transfer Center (TTC) in New Jersey has passed successfully a pre-approval inspection by FDA. The three-day inspection was carried out by Ms. Joy R. Kozlowski-Klena, a compliance officer at FDA's Center for Drug Evaluation and Re…

  • FDA Approves FluMist for Young Children

    September 20, 2007
    MedImmune, Inc. received approval from the FDA for the expanded use of FluMist (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of influenza A and B vi…

  • FDA Approves FluMist for Young Children

    September 20, 2007
    MedImmune, Inc. received approval from the FDA for the expanded use of FluMist (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of influenza A and B vi…

  • Gene Logic, FDA Collaborate on Safety/Efficacy Data

    September 14, 2007
    Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA's Critical Path Initiat…

  • FDA Approves ImClone's Manufacturing Facility

    August 21, 2007
    ImClone Systems, Inc. received approval from the FDA for a second facility to manufacture Erbitux. This new 250,000-sq.-ft. multi-suite manufacturing facility, referred to as "BB50", more than doubles the company's total production capacity…

  • FDA Says New Advair Dose Not Approvable

    August 9, 2007
    The FDA has issued a "not approvable" letter for GlaxoSmithKline's sNDA for the 500/50 strength of Advair Diskus for the treatment of chronic obstructive pulmonary disease (COPD). Specifically, the agency questioned how the new dose compare…

  • FDA Says New Advair Dose Not Approvable

    August 9, 2007
    The FDA has issued a "not approvable" letter for GlaxoSmithKline's sNDA for the 500/50 strength of Advair Diskus for the treatment of chronic obstructive pulmonary disease (COPD). Specifically, the agency questioned how the new dose compare…

  • FDA Approves Roche's Low-Dose Tamiflu

    July 3, 2007
    Roche received approval from the FDA for its sNDA to market Tamiflu capsules in 30 mg and 45 mg doses. The lower dose capsules provide an alternative for the treatment and prevention of influenza types A and B in patients one year and older. The caps…

  • FDA Approves Roche's Low-Dose Tamiflu

    July 3, 2007
    Roche received approval from the FDA for its sNDA to market Tamiflu capsules in 30 mg and 45 mg doses. The lower dose capsules provide an alternative for the treatment and prevention of influenza types A and B in patients one year and older. The caps…

  • SGS Passes FDA Inspection in India

    June 28, 2007
    SGS India Ltd.'s Chennai facility has passed an FDA inspection conducted in February 2007. It was both a pre-approval and a GMP inspection. The facility is classified as "acceptable." This was the first FDA inspection of the SGS QC testing…

  • FDA Puts HCV Drug on Fast Track

    June 27, 2007
    ViroPharma, Inc.'s HCV-796 for hepatitis C virus infection has been granted fast track designation by the FDA. HCV-796, an orally dosed non-nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (H…

  • FDA Puts HCV Drug on Fast Track

    June 27, 2007
    ViroPharma, Inc.'s HCV-796 for hepatitis C virus infection has been granted fast track designation by the FDA. HCV-796, an orally dosed non-nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (H…

  • Senate Initiates Pathway for FDA Approval of Biogenerics

    June 25, 2007
    Under legislation to be introduced in the U.S. Senate, makers of generic drugs would gain the right to market generic versions of biopharmaceutical medicines. The legislation would create a pathway for the FDA to approve generic treatments made throu…

  • Pfizer's Lyrica Gains FDA Approval for Fibromyalgia

    June 22, 2007
    Pfizer received approval for Lyrica capsules for the management of fibromyalgia, a chronic, widespread pain condition affecting more than six million Americans. Characterized by relentless chronic pain, fibromyalgia is usually accompanied by poor sle…

  • Pfizer's Lyrica Gains FDA Approval for Fibromyalgia

    June 22, 2007
    Pfizer received approval for Lyrica capsules for the management of fibromyalgia, a chronic, widespread pain condition affecting more than six million Americans. Characterized by relentless chronic pain, fibromyalgia is usually accompanied by poor sle…

  • FDA Approves Exforge for Hypertension

    June 22, 2007
    Novartis received approval from the FDA for Exforge, a once-daily tablet combination of two high blood pressure medicines: Diovan, an angiotensin receptor blocker, and Norvasc, a calcium channel blocker. The approval was supported by an extensiv…

  • FDA Approves Exforge for Hypertension

    June 22, 2007
    Novartis received approval from the FDA for Exforge, a once-daily tablet combination of two high blood pressure medicines: Diovan, an angiotensin receptor blocker, and Norvasc, a calcium channel blocker. The approval was supported by an extensiv…

  • FDA Approves Cephalon's Nuvigil

    June 18, 2007
    Cephalon, Inc. received approval from the FDA to market Nuvigil Tablets, a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sl…

  • FDA Approves Cephalon's Nuvigil

    June 18, 2007
    Cephalon, Inc. received approval from the FDA to market Nuvigil Tablets, a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sl…

  • FDA Advisory Committee Votes Against Obesity Drug

    June 14, 2007
    The FDA Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of Sanofi-Aventis' rimonabant (Zimulti / Acomplia) to the FDA for use in obese and overweight patients with associated risks factors. The company will continue t…

  • FDA Advisory Committee Votes Against Obesity Drug

    June 14, 2007
    The FDA Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of Sanofi-Aventis' rimonabant (Zimulti / Acomplia) to the FDA for use in obese and overweight patients with associated risks factors. The company will continue t…

  • PDMA and State Pedigree Activity

    Gary C. Messplay, J.D. || June 4, 2007
    Will states advance e-pedigree programs?