Drugs
FDA has approved an Allergan supplemental NDA for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar was previously approved for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of Bipolar I disorder in adults. Without maintenance treatment, 60 to 71% of schizophrenia
FDA Policy/General
Comments Sought on Condom Labeling Info Collection Federal Register notice: FDA seeks comments on an information collection for “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” 11/09/2017 Upcoming Blood Products Advisory Committee Meeting Federal Register notice: FDA announces an 11/
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
Biologics
FDA has approved a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against hepatitis B infection in adults 18 years of age and older. Approval was based on data from three Phase 3 non-inferiority trials of nearly 10,000 adults who received Heplisav-B.
Devices
FDA has cleared a Lensar 510(k) for its IntelliAxis-L, the company’s latest astigmatism management feature to guide toric intraocular lens (IOL) alignment in cataract surgery procedures. This feature for the femtosecond laser platform provides “intraoperative imaging to precisely and permanently identify the location of the steep corneal
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
Devices
FDA says it is no longer adding new adverse event codes for Medical Device Reporting (MDR) in response to device manufacturer requests. As part of an adverse event harmonization effort with the International Medical Device Regulators Forum (IMDRF), FDA expects to transition to the new coding as new annexes from
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,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” The document provides recommended labeling intended to provide important information for condom users, including the extent of protection provided by condoms against
FDA Policy/General
Federal Register notice: FDA has announced an 11/30 to 12/1 Blood Products Advisory Committee advisory committee meeting. Panel members will meet in an open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion.
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
FDA Policy/General
Federal Register notice. FDA has announced the availability of a draft guidance for industry on “Use of a Drug Master File for Shared System REMS Submissions.” The document provides information to applicants who are part of a shared REMS system on using an electronic Type V Drug Master File. To
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
Devices
FDA has cleared a DT MedTech 510(k) for its Hintermann Series H2 Total Ankle Replacement System. The semi-constrained, total ankle replacement prosthesis is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis, primary arthritis
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
FDA Policy/General
Bloomberg News reports that former Eli Lilly executive Alex Azar is expected to be named HHS secretary, replacing former Rep. Tom Price, who resigned after his extensive use of private and military jets at taxpayer expense was documented. Bloomberg cautioned that President Donald Trump is in the midst of an
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