Drugs
Three FDAers write in an online Nature comment that since approval of the Orphan Drug Act in 1983, the agency has approved more than 600 orphan drug indications. The article discusses three key issues for maintaining that approval trajectory for rare disease therapies: * a science-based rationale for granting orphan
Drugs
A 2/20-3/24 FDA inspection at Pfizer’s Meridian Medical Technologies manufacturing facility in Brentwood, MO, which holds a contract to produce EpiPen and EpiPen Jr. for Mylan, found significant violations of current good manufacturing practice (CGMP) requirements for combination products, according to a 9/5 Warning Letter
Drugs
FDA is planning to revamp its early pre-clinical involvement with medical product developers as part of a new “Strategic Policy Roadmap” that will be unveiled soon, commissioner Scott Gottlieb told an online Research America 2017 National Health Research Forum in Washington, DC 9/7. New policies are being formulated
Drugs
The Justice Department says Novo Nordisk will pay $58.65 million to resolve allegations brought by whistleblowers that the company failed to comply with an FDA-mandated REMS (risk evaluation and mitigation strategy) for its Type 2 diabetes drug Victoza (liraglutide). A department statement says the resolution includes disgorgement of
Drugs
FDA has released the FDA-483 issued following a 5/22-6/2 inspection at Celltrion, an Inchon, Korea, sterile injectable drug product and drug substance manufacturer. The form lists the inspection observations as: * failing to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed;
Drugs
FDA says it is recommending an increase in dosing of Grifols Therapeutics’ GamaSTAN S/D (immune globulin [human]) when used for hepatitis A (HAV) prophylaxis. An agency notice says the dosage increase is based on recently observed decreasing concentrations of antibodies to hepatitis A in GamaSTAN S/D attributed to
Drugs
AbbVie has submitted an NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, indicated for managing endometriosis with associated pain. The submission is based on data from two replicate Phase 3 clinical studies, showing that elagolix demonstrated superiority compared to placebo in reducing three types of endometriosis-associated
Drugs
The Biotechnology Innovation Organization (BIO) says its members appreciate an FDA compliance policy statement on product identifier requirements under the Drug Supply Chain Security Act that postpones enforcement of the requirements for one year until 11/2018. The association says the agency “provided sufficient notice to stakeholders to plan for
Drugs
FDA is recommending that patients not take the potassium-lowering drug sodium polystyrene sulfate (Concordia’s Kayexalate and generics) at the same time as other medicines taken orally. An agency drug safety communication says a study found that sodium polystyrene sulfate binds to many commonly prescribed oral medicines, decreasing the
Drugs
PharMEDium Services has recalled all unexpired lots of oxytocin compounded with lactated ringers and all unexpired lots of oxytocin compounded with lactated ringers and dextrose products that were produced between 7/6 and 8/29. The action is being taken based on laboratory test results indicating a lower than expected
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. MB Industria Cirurgica Paulista, Brazil (8/4): FDA inspected the firm’s wound dressing manufacturing facility in March and cited significant GMP violations. For example, the firm failed to
Drugs
The Court of Appeals for the District of Columbia has upheld a district court decision that FDA acted appropriately in approving Alkermes’ Aristada during a period of exclusivity for Otsuka’s Abilify Maintena. Otsuka had opposed the Alkermes application, saying approval would violate an ongoing period of marketing exclusivity for
Drugs
Six groups are petitioning FDA to seek removal of oral and transmucosal ultra-high dosage unit (UHDU) opioid analgesics from the market. The groups — Association of State and Territorial Health Officials, National Safety Council, Physicians for Responsible Opioid Prescribing, American College of Medical Toxicology, FED UP! Coalition to End the
Drugs
Insmed plans to seek accelerated approval of its inhaled therapy Alis (amikacin) based on data from the CONVERT study in adult patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex (MAC). The agency previously granted the product a breakthrough therapy designation, fast track status, and
Drugs
FDA has denied a 2/24/15 Public Citizen petition seeking the immediate removal of ketoconazole 200 mg oral tablets (Janssen’s Nizoral and generics) from the market because its risk of fatal liver failure and adrenal insufficiency and its numerous drug interactions outweigh its limited benefits in treating fungal
Drugs
FDA has denied a United Therapeutics April petition asking that the agency not approve any ANDA referencing Tyvaso (treprostinil) inhalation solution unless the application meets conditions set forth in the petition. The agency denial letter says that because FDA must respond to such petitions within 150 days, it is denying
Drugs
FDA has placed a clinical hold on two Cellectis Phase 1 studies involving cell therapy UCART123 in acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN). The hold was ordered after the company reported one death in the BPDCN clinical trial (ABC study). This was the first
Drugs
Nizoral Not Withdrawn Due to Safety/Effectiveness: FDA Federal Register notice: FDA determines that Janssen Research & Development“ Nizoral (ketoconazole) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. 09/01/2017 Guide on Medical Device Panel Meetings Federal Register notice: FDA announces the
Drugs
FDA has given Pfizer’s Mylotarg (gemtuzumab ozogamicin) a new lifeline with an approval for the once-withdrawn drug for treating adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen (CD33-positive AML). The agency also approved Mylotarg for patients aged 2 years and older
Drugs
FDA, National Cancer Institute and the Society of Urologic Oncology are holding a public workshop 11/28 to improve the conduct of adjuvant clinical trials in bladder cancer and kidney cancer by harmonizing definitions and management of disease recurrence. Currently, no standard definition of disease recurrence is used in these
Drugs
CDER has published a new Manual of Policies and Procedures on “Filing Review of Abbreviated New Drug Applications.” The document outlines policies and procedures for conducting an ANDA filing review by the Office of Generic Drugs Division of Filing Review (DFR). It includes DFR reviewer responsibilities when determining whether an
Drugs
FDA is stepping up its safety surveillance on PD-1/PD-L1 inhibitors after an investigational clinical trial involving Merck’s Keytruda (pembrolizumab) in combination with other therapies in multiple myeloma patients “found an excess of deaths for patients receiving Keytruda when combined with these other drugs,” CDER director Janet