Drugs
FDA has accepted for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor for treating attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults. The submission is based on data from multiple placebo-controlled safety and efficacy studies involving about 2,500
Drugs
FDA has cleared a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner. The device features “Spectral Imaging” capabilities to perform image acquisition and processing at multiple energy levels for computed tomography. Neusoft says the scanner also offers 0.259 second rotation speed for high
Drugs
FDA has approved a Heron Therapeutics NDA for Cinvanti (aprepitant) injectable emulsion, a P/neurokinin-1 receptor antagonist indicated in adults, in combination with other antiemetic agents, for preventing acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. The therapy is also
Drugs
FDA has approved a Teligent ANDA for a generic copy of Promius Pharma’s Sernivo, indicated for treating mild-to-moderate plaque psoriasis in patients 18 years of age or older. Annual sales for betamethasone dipropionate are about $43 million, according to QuintilesIMS Health data.
Drugs
FDA is continuing to take Indian drug manufacturers to task over compliance with agency regulations. The latest sees FDA issuing a combined Warning Letter to India-based Lupin after two drug manufacturing facilities at Goa and Indore were inspected earlier this year and investigators documented significant GMP violations. At Goa,
Drugs
Insys Therapeutics is petitioning FDA to not approve any ANDA referencing its Syndros (dronabinol) oral solution if the ANDA relies on an agency waiver of bioequivalence studies. The petition also asks FDA to require ANDA applicants for generic Syndros to include fed and fasted state bioequivalence studies. “Insys is concerned
Drugs
FDA has issued a guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle, to assist drug sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle. The document specifically addresses the agency’s current thinking about FDA-regulated drugs for which
Drugs
FDA has approved Merck’s Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion, indicated for preventing cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant. CMV is a common and potentially serious viral infection in such
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) describing how the review of original ANDAs, ANDA amendments, and ANDA supplements will be prioritized within the Office of Generic Drugs and the Office of Pharmaceutical Quality. The MAPP establishes public health priorities (prioritization factors) that may qualify an original
Drugs
FDA has approved a Seattle Genetics’ supplemental BLA for Adcetris (brentuximab vedotin) for treating adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy. Approval was based on data from the ALCANZA Phase 3 trial that showed an objective response
Drugs
FDA has accepted an Otsuka Pharmaceutical Co. NDA resubmission for tolvaptan and its expanded use in treating adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The agency rejected an earlier submission in 2013, requesting additional data to further evaluate the product’s safety and efficacy in patients with ADPKD. The
Drugs
FDA has awarded Advanced Clinical Trials for Children (IACT for Children) and Duke University $1 million each to help advance pediatric clinical trials. The grants are intended to fund research that will “help academia and industry-based institutions overcome some of the historic challenges posed by pediatric clinical trials,” says
Drugs
FDA has denied a Vifor Fresenius Medical Care Renal Pharma 7/12 petition asking that FDA not approve a pending sNDA for Auryxia (ferric citrate) submitted by Keryx Pharmaceuticals. The petition asked that FDA only consider the proposed iron deficiency anemia (IDA) indication after Keryx submits an additional NDA containing
Drugs
FDA commissioner Scott Gottlieb says the agency is looking at steps it can take to reduce the likelihood that branded drug companies can use the existence of a Risk Evaluation and Mitigation Strategy (REMS) as a way to slow the entry of generic competition. In a statement, Gottlieb said the
Drugs
The Better Business Bureau’s National Advertising Division (NAD) has referred advertising claims made by Synergy Pharmaceuticals to the Federal Trade Commission after the drug company declined to participate in a NAD proceeding. NAD says the Synergy claims for its Trulance (plecanatide) chronic idiopathic constipation prescription drug made in online
Drugs
The use of real-world evidence (RWE) and data is growing and assuming great importance for drug companies in drug development, patient safety, and commercialization. That’s a key takeaway from a Tufts Center for the Study of Drug Development survey of 30 drug companies to assess current and planned
Drugs
Stericycle Expert Solutions says that medical device recalls fell 39% to 167 in the third quarter of 2017. It was the lowest quarter for the industry since the fourth quarter of 2011. Despite the steep drop, however, the group says, recalled units increased 1% to 68 million. “The main reason
Drugs
FDA says it has received an adverse event report that two patients developed tissue erosion at the injection site following the administration of an injectable glutamine, arginine, and carnitine (GAC) product that was compounded by United Pharmacy, West Palm Beach, FL. The adverse event report indicated that a sample of
Drugs
FDA has approved a Collegium Pharmaceutical supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The sNDA approval,
Drugs
Commenting on Amgen’s federal court suit challenging FDA’s denial of six-months pediatric exclusivity for its Sensipar (cinacalcet), Yale Law School professor Jeanie Kim says in a JAMA Network online article that courts should defer to the agency’s current policy that links “fairly respond” to a study’
Drugs
FDA has approved a Roche PMA for the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer patients eligible for treatment with Genentech’s (a Roche subsidiary) Alecensa (alectinib). Alecensa gained approval 11/7 based on data from
Drugs
A Federal Trade Commission Bureau of Competition report says that for FY 2015, drug companies filed 170 agreements as final resolution of patent disputes between brand and generic drug manufacturers, including 14 settlements that potentially involved pay-for-delay because they contained both explicit compensation from a brand manufacturer to