USFDA

(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.

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.

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.

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.

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.

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.

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.

Karkhadi (Gujarat) based plant of Sun Pharmaceuticals imposed ban by USFDA. This ban is applied on import of all drug products from this plant. This detention was carried out without physical examination of drugs because company failed to met good manufacturing practices rules, as per FDA website on Wednesday.

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.

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