• 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.

  • Continued USFDA approval for oral dosage facility in Strides Arcolab

    (28th April, 2014); Strides Arcolab announced on 25th April that its Oral Dosage Forms  manufacturing site (KRS Gardens) in Bangalore was recently inspected by the USFDA as part of  GMP compliance audit and the facility continues to be approved.

  • New anti-diabetic drug Tanzeum got FDA approval

    The U.S. Food and Drug Administration approved Tanzeum (albiglutide), manufactured by GlaxoSmithKline, subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

  • Stallergenes's Oralair - sublingual allergen extract gets approval from FDA

    Recently, U.S. Food and Drug Administration approved Oralair, first sublingual allergen extract approved in the United States, to treat allergic rhinitis with or without conjunctivitis that is induced by certain grass pollens in age group of 10 to 65 years. Oralair contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.

  • New drug approved for treating psoriatic arthritis by FDA

    The U.S. Food and Drug Administration approved Otezla (apremilast), manufactured for Celgene Corporation, Summit, N.J.,  to treat adults with active psoriatic arthritis (PsA), which is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA.

  • FDA approves first implantable hearing device

    The U.S. Food and Drug Administration approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.

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