An accelerated approval has been granted by the FDA to AbbVie's Imbruvica, or ibrutinib, allowing its use as a treatment for marginal zone lymphoma in patients who need systemic therapy after receiving one or more prior anti-CD20-based treatments. The decision was based on results of a midstage study.
A draft guidance to help sprout operations meet new standards under the Food Safety Modernization Act has been released by the FDA. The guidance, which is open for public comment for the next six months, requires sprout suppliers to take measures to keep seeds or beans used for sprouting safe from dangerous microbes and to test spent irrigation water for the presence of pathogens.
Skin cancer creams containing the active ingredient fluorouracil -- which are sold under the brand names Fluoroplex, Carac and Efudex -- might be fatal if ingested by animals, the FDA warns. Five dogs have reportedly been sickened and died after consuming the skin creams.
Allergan has received FDA approval for Rhofade, or oxymetazoline hydrochloride 1% cream, as a topical treatment for adults with persistent facial erythema due to rosacea. The approval was backed by data from two trials involving 885 adults who saw reduction in the condition for 12 hours with use of the treatment.
Synergy Pharmaceuticals' once-daily tablet Trulance, or plecanatide, has been approved by the FDA to treat adult patients with chronic idiopathic constipation. The approval was based on positive results from two late-stage trials.
Shire's Class 2 resubmission of its new-drug application for attention-deficit/hyperactivity disorder candidate SHP465 has been received by the FDA, with an action date on or around June 20. The firm submitted its original NDA in July 2006 but received a request from the agency the following May to conduct additional clinical studies.
A supplemental new drug application has been submitted by UCB to the FDA for Briviact, or brivaracetam, as a monotherapy for partial-onset seizures in patients with epilepsy who are at least 16 years old. The drug is already approved as an adjunct therapy for the condition.
The National Institute for Health and Care Excellence has set a new drug impact threshold criteria to better manage the budget effect of introducing new treatments endorsed for National Health Service use that could delay routine access to one in five new drugs approved. Under the new criteria, the availability of an approved drug will be delayed if it would cost the agency $24.59 million a year or more in any of the first three financial years after its approval.
CyMedica Orthopedics has obtained clearance from the FDA to market its wireless muscle stimulation device called e-vive, which is intended to provide muscle strength rehabilitation in anterior cruciate ligament and total knee replacement patients. The app-controlled device is a patient engagement solution that monitors patient progress and enables sharing of data with clinicians.
The FDA has given Parsippany, N.J.-based Precision Spine clearance to market its ShurFit ACIF 2C anterior cervical interbody system, which is designed for treating patients with degenerative disc disease in their cervical spines. The system, made from medical grade polyetheretherketone, is coated with hydroxyapatite and titanium for promoting bony growth.
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