Drugs
FDA has approved a Teva Pharmaceutical Industries NDA for Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for asthma maintenance treatment in patients aged four years and older. The inhaler is not indicated for relieving acute bronchospasm, the company says. The approval is supported by safety and
FDA Policy/General
Federal Register notice: FDA has announced a 9/13 Vaccines and Related Biological Products Advisory Committee meeting. The panel will review the safety and effectiveness of GlaxoSmithKline Biologicals’ zoster vaccine recombinant. To view the notice, click here.
Drugs
FDA has issued Vernalis a complete response letter (CRL) on its NDA for CCP-08, an undisclosed extended-release product being developed for Vernalis by Tris Pharma for the U.S. prescription cough-cold market. A CRL was issued to Vernalis for another undisclosed product in April (see story). The
FDA Policy/General
Guide on Child-Resistant Packaging Statements Federal Register notice: FDA announces the availability of a draft guidance on “Child-Resistant Packaging Statements in Drug Product Labeling.” 08/03/2017 FDA Withdraws Approval for 4 B. Braun Medical Drugs Federal Register notice: FDA announces that it is withdrawing approval of three
Drugs
FDA has tentatively approved a Perrigo ANDA for a generic version of Galderma Labs’ Mirvaso (brimonidine) topical gel 0.33%, indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. Perrigo recently settled litigation with Galderma and Nestle Skin Health S.
Drugs
Eli Lilly says its investigational migraine drug lasmiditan met its primary endpoint in SPARTAN, a second Phase 3 study of the therapy. A greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo after two hours, it says. The results were statistically significant across all three
Drugs
FDA has granted Omeros an orphan drug designation for OMS721 for treating Immunoglobulin A (IgA) nephropathy. The human monoclonal antibody is designed to target mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system, according to the company. IgA nephropathy
Drugs
FDA is warning healthcare professionals about hypersensitivity reactions related to ImprimisRx’s curcumin (a component of the spice turmeric) compounded with polyethylene glycol 40 castor oil. An agency safety alert says that earlier a 30-year-old female patient experienced cardiac arrest after IV administration of the product. “Within minutes
Drugs
A Utah federal judge has entered a consent decree of permanent injunction against Isomeric Pharmacy Solutions (Salt Lake City), co-owners William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown. The court action bars them from manufacturing, processing, packing, holding, or distributing drugs until they
Drugs
FDA has granted Applied Genetic Technologies an orphan drug designation for its unidentified gene therapy product candidate for treating X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene. XLRP is an inherited condition that causes progressive vision loss, beginning with night blindness in young boys followed by
Devices
FDA has cleared a Standard Bariatrics 510(k) for the Standard Clamp, a disposable laparoscopic surgical clamp that is intended to assist surgeons performing laparoscopic sleeve gastrectomy, said to be the most common and effective weight loss surgery. The company says that more than 60% of patients seeking a surgical
FDA Policy/General
Medical product user fees account for 38% of FDA’s funding, but when you add tobacco user fees, which fund 100% of the agency’s tobacco-related programs, they raise the overall user fee percentage to 47%. The tobacco fees skew the budget numbers and may detract from legitimate budget
Drugs
Daiichi Sankyo says it will settle on behalf of its companies and Forest entities pending product liability litigation involving olmesartan products (Benicar, Benicar HCT, Azor, and Tribenzor). The suits, filed beginning in 1/2014, allege that the products cause sprue-like enteropathy and other severe gastro-intestinal symptoms, the company
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance on “Child-Resistant Packaging Statements in Drug Product Labeling.” The document is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-the- counter human drug product
FDA Policy/General
Federal Register notice: FDA has announced that it is withdrawing approval of three NDAs and one ANDA held by B. Braun Medical. The company notified the agency that the products are no longer marketed and requested that the approval of the applications be withdrawn. Affected products include Dextran 70 (6%
Drugs
FDA has approved Jazz Pharmaceuticals’ Vyxeos, a fixed combination of daunorubicin and cytarabine, for treating adults with two types of acute myeloid leukemia (AML). The agency says in a news release that the two types are newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-
Drugs
FDA says that Rugby Laboratories is recalling all lots of its Diocto Liquid and Diocto Syrup (docusate sodium solutions) manufactured by PharmaTech due to a risk of product contamination with Burkholderia cepacia. An agency MedWatch notice says FDA informed Rugby that it received several adverse event reports of B. cepacia
Drugs
FDA’s Arthritis Advisory Committee has voted 12 to 1 against recommending approval of a Janssen Biotech BLA for Plivensia (sirukumab), citing safety concerns raised in an FDA briefing document released in advance of the meeting. Its major safety findings were related to immunosuppression consistent with other disease-modifying anti-
Drugs
Former Office of New Drugs director John Jenkins delayed his planned retirement last year because he was worried that his boss, CDER director Janet Woodcock, would step in as acting director and damage the new drugs review program. This revelation comes from a new email released under a Freedom of
Drugs
The Senate has voted 94-1 vote to pass an FDA user fee reauthorization bill to fund agency product reviews and related activities for the next five years. Senator Bernie Sanders (I-VT) was the lone vote against the measure. The House passed a similar bill earlier this summer. “The
Drugs
Former CDC director Thomas Frieden says that while randomized clinical trials have been considered the “gold standard” of medical research, they can have significant limitations, and other means of collecting and analyzing data can be better in some situations. Writing in The New England Journal of Medicine, Frieden says there
Drugs
FDA says it has updated its Risk Evaluation and Mitigation Strategy (REMS) Web site and structured product labeling (SPL) initiatives. The announcement says the updates are a result of feedback received from stakeholders who asked that the agency provide information on REMS programs in a more direct and user friendly