USFDA

Egalet Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets. ARYMO ER is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.

Cellceutix Corporation is pleased to announce that it has submitted a Special Protocol Assessment (SPA) request, along with a final protocol to FDA, for a phase 3 clinical trial of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). A SPA is a written agreement between the U.S. Food and Drug Administration (FDA) and a drug sponsor detailing the clinical trial design, endpoints and other clinical trial facets that can be used to support regulatory approval, thereby potentially reducing the risk of bringing a drug to market. The SPA submission is the next step in beginning a phase 3 program in ABSSSI after a successful End-of-Phase 2 Meeting with FDA last July (2015).   The title of the protocol submitted with the SPA request is:

Novartis  announced that the United States Food and Drug Administration (FDA) approved Afinitor® (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Afinitor received a priority review designation providing a shortened review period for drugs that treat serious conditions and offer a significant improvement in safety or effectiveness.

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Teligent, Inc. a New Jersey-based specialty generic pharmaceutical company, announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Desoximetasone Ointment USP 0.25%, the generic equivalent of Topicort® Ointment, 0.25%, of Taro Pharmaceuticals U.S.A., Inc.

Zoetis Inc. announced that the U.S. Food and Drug Administration (FDA) has approved SimparicaTM (sarolaner) Chewables to kill adult fleas and prevent flea infestations, as well as treat and control tick infestations due to the Lone Star tick, the Gulf Coast tick, the American dog tick, and the brown dog tick.

Asterias Biotherapeutics, Inc. announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, its investigational therapy targeting acute myeloid leukemia (AML).

AMAG Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the company’s single-dose, preservative-free formulation of Makena® (hydroxyprogesterone caproate injection). Makena is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past.

Boston Scientific  has received U.S. Food and Drug Administration (FDA) approval for the ACUITY™ X4 Quadripolar Left Ventricular (LV) leads. The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the leads – to the U.S. market.

Medtronic plc announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication trial for the CoreValve® Evolut® R System, the first and only next-generation recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system commercially available in the United States. Patients with aortic stenosis, who are at a low surgical mortality risk as determined by a heart team, will be enrolled in the trial.