Drugs
An FDA safety alert says that opioid addiction medications buprenorphine and methadone should continue to be given to patients taking benzodiazepines or other drugs that depress the central nervous system, even though their combined use increases the risk of serious side effects. The agency contends that the harm caused by
Drugs
FDA has told Lipocine that the agency’s Bone, Reproductive and Urologic Drugs Advisory Committee plans to discuss the company’s NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism). The advisory committee meeting
Devices
FDA has cleared a Stryker Spine division 510(k) for its Tritanium C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine. The device is constructed from Stryker’s proprietary Tritanium In-Growth Technology, a highly porous titanium material designed for bone in-
Drugs
Pfizer has filed suit in Pennsylvania federal court against Johnson & Johnson and its Janssen Biotech unit for antitrust violations in blocking competition from Pfizer’s biosimilar Inflectra (infliximab-dyyb) to protect Janssen’s Remicade (infliximab). The suit says the case is about J&J “imposing a web of
Drugs
FDA says that opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other central nervous system depressants. An agency drug safety communication says the “combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction
Drugs
The CDER Office of Drug Security, Integrity, and Response has sent Warning Letters to 13 Internet-based companies operating scores of individual Web sites that the agency says are offering unapproved new drugs and misbranded drugs for sale in U.S. commerce. The 13 companies are 247Med, Pharm Cash, Glay
Devices
FDA has cleared a Pentax of America 510(k) for the first duodenoscope with a disposable distal cap, a new feature that is intended to improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is indicated for use in visualizing and accessing to the upper gastrointestinal (GI)
Devices
Barnes & Thornburg attorneys say that the FDA Reauthorization Act of 2017 requires changes to FDA inspections of medical device manufacturers. In an online blog post, the attorneys say the law requires the agency to implement a risk-based schedule for inspecting manufacturers of Class 2 and 3 devices. There
Drugs
An 11/3-11/11/16 FDA inspection at Firson Company, Chungcheongnam-do, Korea, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to an 8/31 Warning Letter. Specific violations noted in the letter were: * failing to establish and follow appropriate written procedures designed to
Drugs
FDA has approved a GlaxoSmithKline and Innoviva NDA for a once-daily, single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), indicated for long-term maintenance treatment of patients with chronic obstructive pulmonary disease, including chronic bronchitis or emphysema. The therapy is intended for patients who are on a
Devices
FDA has cleared an Arkis BioSciences 510(k) for its new external ventricular drainage catheter, CerebroFlo. The device is intended for insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid in patients with elevated intracranial pressure, intraventricular hemorrhage, or hydrocephalic shunt infections, according to the
Drugs
A 3/6-3/10 FDA inspection at Wuxi Medical Instrument Factory, Wuxi City, Jiangsu, China, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 9/7 Warning Letter. Specific violations noted in the letter were: * failing to establish written procedures for production and
Devices
A 4/21-5/19 FDA inspection at Preservation Solutions, Elkhorn, WI, found Quality System regulation issues in the firm’s manufacturing of organ transplant preservation solutions, which are regulated as medical devices. Violations cited in an 8/21 Warning Letter were: * failing to adequately validate, according to established procedures,
FDA Policy/General
FDA is developing a guidance document on real world evidence (RWE) consensus definitions that is intended to help advance RWE use in pre- and post-market review processes, FDA commissioner Scott Gottlieb told a National Academy of Sciences 9/19 workshop in Washington, DC. The definitions will relate to how
FDA Policy/General
Federal Register notice: FDA is extending the comment period for the public meeting on “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The agency is seeking public input to help ensure that the law’s intended balance between encouraging innovation in drug development and accelerating the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Firson Co. Chungcheongnam-do, Korea (8/31): FDA inspected the firm 11/2016 and cited it for significant GMP violations for finished pharmaceuticals. Agency investigators determined that the firm
Drugs
FDA has denied a Boehringer Ingelheim petition seeking to have FDA impose conditions for approving any NDA for a fixed-dose, triple-combination, inhaled drug product intended to treat patients with chronic obstructive pulmonary disease (COPD). In its denial letter, the agency said it was approving GlaxoSmithKline’s Trelegy Ellipta
Drugs
FDA’s Oncologic Drug Advisory Committee has voted six in favor and six against the benefit-risk profile for Pfizer’s Sutent (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after surgical removal of the cancer-containing kidney. FDA has set a
Drugs
The Post-Finasteride Syndrome Foundation is asking FDA to immediately withdraw marketing approval for Merck’s Propecia and generic formulations of finasteride 1 mg for androgenic alopecia “because the risk of serious injury from the drug outweighs its limited benefits.” The foundation says that an alternative request would be to
Drugs
The Association for Accessible Medicines (AAM) says that a draft FDA guidance on “Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions,” represents a fundamental departure from the GDUFA 2 comment letter and may unintentionally discourage ANDA sponsors from submitting a priority review request. In its comment
Drugs
Continuing FDA safety concerns involving PD-1/PD-L1 inhibitors have spread to two Roche clinical trials. A Phase 1b and Phase 1b/2 involving Tecentriq have been placed on partial clinical hold, according to Roche. Last month, CDER director Janet Woodcock said the agency was stepping up its safety
Drugs
FDA has approved a Symbiomix Therapeutics NDA for Solosec (secnidazole) 2g oral granules for treating bacterial vaginosis (BV) in adult women. The next-generation, 5-nitroimidazole antibiotic is designed with enhanced pharmacokinetic properties that enable delivery in a single dose, according to the company. Approval was based on data from