USFDA

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.

U.S. FDA approval for Eliquis® (apixaban) to reduce risk of thrmobosis in Hip or Knee Replacement Surgery

Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

GSK marketed products Mekinist in combination with Tafinlar received FDA nod for Advanced Melanoma

FDA approved combination therapy of Mekinist (trametinib) and Tafinlar (dabrafenib) for treatment of advanced melanoma that is unresectable or metastatic. In May 2013, FDA had already approved both drugs as single agents to treat patients with unresectable or metastatic melanoma, skin cancer.

FDA issued warning letter against Indian based Canton Laboratories upon quality issues

During  their last investigation in April 2013 at Canton Laboratories- Vadodara,  U.S. food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) and in view of it, FDA issued a warning letter.

Cefaly gets FDA approval for marketing - First medical device approved to prevent migraine

U.S. Food and Drug Administration allowed marketing of the first device, Cefaly-manufactured by STX-Med in Belgium, as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

Collaboration in pharmacovigilance strengthen by FDA and EMA

A new "cluster" have set up on medicinal safety topics by join efforts of U.S. Food and Drug Administration and the European Medicines Agency (EMA). Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration.

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