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  • The Food and Drug Administration (FDA) is insisting the regulations in this regard are strictly followed. This ensures the products that come into the US are of the highest quality, have safety built into them and are effective. The US Food and Drug Administration (FDA) is increasing the frequency of inspections in India.

  • Novo Nordisk today announced the company will launch Novoeight® (Antihemophilic Factor [Recombinant]) in the United States for people living with hemophilia A. Novoeight® offers purity, reliability, and enhanced portability, with the highest storage temperature for the longest period of time compared with other marketed recombinant Factor VIII products—up to 86 degrees F for 12 months. It can be kept at that temperature for up to 4 hours after reconstitution, giving it the longest postreconstitution storage time. Novoeight® offers purity through a 5-step purification process. It was shown to be safe and effective in clinical trials with zero inhibitors confirmed in 213 previously treated patients with hemophilia A. Novo Nordisk plans to make Novoeight® available by mid-April 2015.

  • The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

  • U. S. Food and Drug Administration granted accelerated approval to palbociclib (IBRANCE, Pfizer, Inc.) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.

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  • 16 January 2015
    USFDA approves first-of-kind device to treat obesity - VBLOC

    The U.S. Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
    The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.

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  • The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

  • (2nd September, 2014); Wockhardt Ltd’s New Drug Discovery program in Anti - Infective research received a major boost after two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from the US FDA. This is the first instance of an Indian Pharmaceutical company receiving a QIDP status.

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  • (31st July, 2014); U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). The recommended dosage of EYLEA in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.


  • (22nd May, 2014);The U.S. Food and Drug Administration (FDA) approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test (BeadChip Test), manufactured by BioArray Solutions Ltd. of Warren, New Jersey, the first FDA-approved molecular assay used in transfusion medicine to assist in determining blood compatibility. The assay can be used to determine donor and patient non-ABO/non-RhD (non-ABO) red blood cell (RBC) types in the United States.

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