USFDA

Viamet Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to VT-1161, a novel oral agent for the treatment of recurrent vulvovaginal candidiasis (RVVC), or recurrent vaginal yeast infection, a common and difficult to treat condition in women. There are no approved therapies in the United States for RVVC.

Mylan NV announced the US launch of metformin hydrochloride extended-release tablets USP, 500 mg and 1000 mg, a generic version of Watson's Fortamet. Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Jubilant Pharma Ltd, announced that the U.S. Food and Drug Administration has approved RUBY-FILL®, an innovative technology for Positron Emission Tomography (PET) myocardial perfusion imaging (MPI). Comprised of a Rubidium-82 (Rb-82) Generator and precedent setting Elution System, RUBY-FILL® is used to produce a personalized patient dose of Rubidium Rb 82 chloride used to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease (CAD) which is an important component of diagnosing CAD.

Medtronic plc  announced that the U.S. Food and Drug Administration (FDA) has cleared the TrailBlazer(TM) angled support catheter for use in the peripheral vascular system. Support catheters such as the Trailblazer are often used in endovascular procedures treating complex peripheral artery disease (PAD).  FDA clearance was received on September 23, 2016.

Amgen and UCB  announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

BrainScope Company, Inc. announced that the United States Food and Drug  Administration (FDA) has cleared the company to market the Ahead 300, its most  advanced medical device for use in assessing traumatic brain injury (TBI). Developed in  partnership with the U.S. Department of Defense, the Ahead 300 provides a multi-modal  device of clinically relevant measures, offering clinicians a comprehensive panel of data  to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead  300 represents an evolution from the three BrainScope products that have previously  received FDA clearance, and with its substantial additional capabilities, will be the first  product the company will sell commercially. 

Pain Therapeutics, Inc.  announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for REMOXY ER (oxycodone capsules CII).  The CRL informs that REMOXY ER cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.

Janssen Research & Development, LLC announced that a supplemental New Drug  Application (sNDA) for ibrutinib (IMBRUVICA ® ) has been submitted to the U.S. Food and  Drug Administration (FDA) for the treatment of patients with marginal zone lymphoma  (MZL) who require systemic therapy. The filing is based on data from the multi-center, open-  label Phase 2 PCYC-1121 trial assessing the use of ibrutinib, a BTK inhibitor, in patients  with MZL who have received at least one prior therapy.

Janssen Biotech, Inc., announced that the U.S. Food and Drug Administration (FDA) has  approved STELARA ® (ustekinumab) for the treatment of moderately to severely active  Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment  with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis  factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF  blockers. STELARA ® is the first biologic therapy for Crohn’s disease targeting interleukin  (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses.