Drugs
FDA has approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly’s Trijardy XR (empagliflozin/linagliptin/metformin HCl) to lower blood sugar in adults with Type 2 diabetes, along with diet and exercise. Trijardy XR comprises three Type 2 diabetes medicines in one pill, including Jardiance, Tradjenta and metformin extended release. Approval
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Baja Fur City of Industry, CA (12/13): FDA inspected the firm in July and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of a new animal drug application and two abbreviated new animal drug applications at the sponsors’ request because they are no longer manufactured or marketed. The products are Fleming Laboratories’ NADA for Wazine (dipiperazine sulfate and piperazine HCl); Halocarbon Products ANADA for halothane;
FDA Policy/General
Federal Register notice: FDA has extended until 3/19 the comment period for its draft guidance on “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials.
Drugs
FDA is seeking comments on two proposed studies entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.” The agency intends to examine four types of endorsers in the studies (celebrity, physician, patient, and social media influencer) and it will examine whether the presence of a disclosure of
Drugs
FDA has accepted for review a Corium 505(b)(2) NDA for Adlarity (donepezil transdermal system), for treating Alzheimer’s-type dementia. The agency has set a 7/30 user fee review target action date. The company describes Adlarity as a once-weekly transdermal formulation of Pfizer’s Aricept that
Devices
FDA has cleared a GT Medical Technologies 510(k) for an expanded indication for GammaTile Therapy — surgically targeted radiation therapy in patients with newly diagnosed malignant brain tumors. GammaTile features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source, Cesium-131, GT Medical says. It is placed at the
Drugs
FDA has approved Merck’s Dificid (fidaxomicin) oral suspension and tablets for treating Clostridium (also known as Clostridioides) difficile infections in children aged six months or older. The macrolide antibacterial was previously indicated in adults for treating Clostridium difficile-associated diarrhea. Difficile is a bacterium that causes diarrhea and colitis,
Devices
FDA has released a draft guidance on “Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions” that provides recommendations for device design considerations, risk mitigation strategies, and testing recommendations. The devices are designed to deliver irrigation fluid to surgical sites (knee, shoulder, hip, etc.) during
Devices
FDA has launched a new Web page to help companies advance development of novel coronavirus medical countermeasures. Faced with growing concern about the spreading virus, the agency says it will “collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products
FDA Policy/General
Federal Register notice: FDA has made available two final guidances entitled “Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions” and “In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.” The guidances are intended to assist drug developers in evaluating drug-drug interaction
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher for the approval of a rare pediatric disease product application — Sarepta Therapeutics’ Vyondys 53 (golodirsen) for treating Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. To view
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Draft Guidance for Levonorgestrel.” The document provides product-specific recommendations on bioequivalence studies to support ANDAs for a levonorgestrel intrauterine device. To view the notice, click here.
Drugs
FDA has released a final guidance on “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials or to support drug
FDA Policy/General
Federal Register notice: FDA has announced a 2/26 Oncologic Drugs Advisory Committee meeting. During the morning session, the panel will discuss a Steba Biotech NDA for padeliporfin di-potassium powder for solution for treating patients with localized prostate cancer. In the afternoon, they will discuss an Eli Lilly supplemental
Drugs
FDA is seeking outside groups or individual data scientists for the development of computational algorithms to identify adverse event anomalies in open FDA adverse event data available on its openFDA platform. “Automated adverse event anomaly detection would augment the traditional data mining and case review approach by enabling the unsupervised
Drugs
FDA has granted accelerated approval for Epizyme’s Tazverik (tazemetostat) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Approval was based on data from a single-arm cohort (Cohort 5) of a multi-center trial (Study
Devices
FDA has approved an expanded indication for Abbott’s Infinity Deep Brain Stimulation (DBS) system to include targeting of an area of the brain called the internal globus pallidus (GPi). The company says the GPi plays an important role in motor function and can be targeted with DBS to improve
Drugs
A Genentech Phase 3 study (IMvigor010) evaluating Tecentriq (atezolizumab) in people with muscle-invasive bladder (urothelial) cancer did not meet its primary endpoint of disease-free survival. The company says more treatment options are needed after surgery because about half of patients will see disease recurrence within two years after
Devices
King Systems has recalled 171 units of its King Vision Video Laryngoscope (adapter size 1/2) because they may display a reversed image, which could potentially result in difficulty navigating during intubation or delay intubation. Affected device images may appear normal, but user’s actions will be reversed on the
Drugs
FDA has published two guidances dealing with drug-drug interactions. The first guidance, In Vitro Drug Interaction Studies—Cytochrome P450 Enzyme- and Transported-Mediated Drug Interaction, is to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product. The document