USFDA

DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER® and EXPEDIUM®Fenestrated Screw Systems. When used in conjunction with CONFIDENCETM High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery.

The US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for AstraZeneca's Symbicort (budesonide/formoterol) inhalation Aerosol.The FDA’s decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to a Written Request (a prerequisite for qualifying for paediatric exclusivity under Section 505A of the Federal Food, Drug, and Cosmetic Act). Symbicort is currently approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults.

Synergy Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved Trulance (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

Symbiomix, a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections, has announced submission of a new drug application (NDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV) to the U S Food and Drug Administration (FDA). Solosec is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, and is anticipated to be the first and only single-dose oral therapy approved for BV.

Shire plc announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. SHP465 is being evaluated as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.

Adamis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s New Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis.  Filed on December 15, 2016, the resubmission was intended to address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (“CRL”).  The FDA indicated that it considered the resubmission to be a complete response to the CRL.

SpineGuard  announced  it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new DSG™ (Dynamic Surgical Guidance) integration module to be used in combination with Zavation’s spinal fusion system to make its pedicle screws “smart.”

Eli Lilly and Company and Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). The NDA for baricitinib was submitted to the FDA in January 2016.

Abbott has announced the US launch and the first commercial uses of the new ensite precision cardiac mapping system and advisor FL circular mapping catheter, sensor enabled to map cardiac arrhythmias during ablation treatments. The first commercial use of the system after US Food and Drug Administration (FDA) clearance occurred at the Intermountain Heart Institute at Intermountain Medical Center in Salt Lake City during ablation procedures conducted by electrophysiologist John Day, M.D.

Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.