Drugs
The Justice Department says the owner of MedFitRX, now known as MedFit Sarmaceuticals, a sports supplement company based in Cary, NC, has been sentenced to one year and one day in federal prison after pleading guilty to introducing unapproved new drugs into interstate commerce. A department statement says that Brian
Drugs
FDA has accepted for priority review an Amgen NDA for sotorasib for treating patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The submission is based on data from the Phase 2 CodeBreaK 100 clinical trial that
Drugs
FDA acting commissioner Janet Woodcock says a Public Citizen proposal to create a “firewall” between agency staff involved in any pre-submission interactions with drug sponsors and FDA staff involved in post-submission NDA or BLA review and decision-making “would cause significant repercussions for public health.” She commented in
Drugs
FDA has accepted for priority review an Amgen NDA for sotorasib for treating patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The submission is based on data from the Phase 2 CodeBreaK 100 clinical trial that
Drugs
Verrica Pharmaceuticals has resubmitted its NDA for VP-102 (cantharidin 0.7% topical solution), a proprietary topical therapy for treating molluscum contagiosum (molluscum). In 7/2020, FDA issued a complete response letter seeking additional chemistry, manufacturing, and controls information and human factors validation. A company notice at the time said
Drugs
An FDA 2020 review of the Web site and Facebook and Instagram pages maintained by Evolved Ayurvedic Discoveries, Encinitas, CA, determined that the company takes orders for several BioCBD+ products that claim to contain cannabidiol. A 2/11 Warning Letter says the Web site offers products that are intended to
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a banner ad and tabletop display for AcelRx’ Dsuvia (sufentanil) sublingual tablets make false or misleading claims and representations about the drug’s risks and efficacy. A 2/11 Warning Letter says oral opioids such as Dsuvia include risks for accidental
Drugs
FDA has approved an expanded indication for Novartis’ Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. The approval notes that benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. The
Drugs
FDA has announced a 3/23 virtual public workshop entitled “Roadmap to 2030 for New Drug Evaluation in Older Adults” to discuss the current status of including older adults in clinical trials and strategies to ensure safe and effective drug use in the elderly. FDA says it is concerned about
Drugs
Federal Register notice: FDA has issued a priority review voucher to Alnylam Pharmaceuticals in response to its rare pediatric disease product application for Oxlumo (lumasiran) injection, indicated for treating primary hyperoxaluria Type 1 to lower urinary oxalate levels in pediatric and adult patients. To view the notice, click here.
Drugs
Ndal Mfg Inc. has recalled one lot of Manukaguard Allercleanse after determining the products were contaminated with yeast. “The use of Allercleanse (manuka honey) nasal spray contaminated with yeasts, in the population most likely to use it (children, adults, and elderly), may result in adverse events that necessitate medical or
Drugs
CDER’s Office of Pharmaceutical Quality (OPQ) says that early this year it will begin using its Knowledge-aided Assessment & Structured Application (KASA) tool for solid oral dosage forms, manufacturing, and biopharmaceutics regulatory assessments. KASA has been under development for years to improve efficiency, effectiveness, and quality assessment consistency
Drugs
The 2020 annual report of the CDER Office of Generic Drugs shows that 948 ANDAs -- 223 or 19% fewer than in 2019 -- were approved or tentatively approved in 2020, including 72 first generic drugs. The report also shows that 187 product-specific guidances were issued for industry and other stakeholders,
Drugs
A new study (STEP) finds that 35% of those taking Novartis’ semaglutide for treating obesity lost more than one-fifth of their total body weight, according to University College London researchers. “Three quarters (75%) of people who received semaglutide 2.4mg lost more than 10% of their body weight and
Drugs
CDER Drug Safety Priorities 2020, the sixth annual report detailing the Center’s safety programs and activities, “highlights key safety-related milestones and accomplishments of 2020 and focuses on the programs and initiatives at the core of CDER’s drug safety operations,” the report says. It also looks at the
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FDA has issued Eli Lilly an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for treating mild to moderate Covid-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms) who test positive for Covid and who are at high risk
Drugs
Fresenius Kabi Oncology is pleading guilty to concealing and destroying records before a 2013 FDA plant inspection and has agreed to pay $50 million in fines and forfeitures. The Department of Justice says that a criminal information filed in Nevada federal court charges the company with violating the Federal Food,
Drugs
FDA has given ERX Pharmaceuticals approval to move to the next level in its Phase 1 study evaluating its ERX1000 leptin sensitizer in treating obesity. The company says ERX1000 “has already demonstrated proof-of-concept in first-in-human studies in obese subjects, having been generally well tolerated at doses
Drugs
Genmab and Seagen have submitted a BLA seeking accelerated approval for tisotumab vedotin, indicated for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin is an investigational antibody-drug conjugate directed to tissue factor, a cell-surface protein expressed on multiple solid
Drugs
An FDA review of a Web site and YouTube channel maintained by Clarke Pharmaceuticals, Webster, TX, found the firm is marketing several unapproved drugs, according to a 2/2 Warning Letter. The letter quotes claims from the firm’s Web site that establish the products are intended for use in
Drugs
FDA has approved Allergan’s Botox for treating detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients aged five years and older who have an inadequate response, or are intolerant, to anticholinergic medications. Allergan says that neurogenic detrusor overactivity occurs when the spinal cord and bladder are
Drugs
A group of Democrats on the House Oversight Committee are urging FDA to remove the in-person dispensing requirement for medical abortion drug mifepristone. Last month, the U.S. Supreme Court in a 6-3 split on ideological lines granted an FDA request to reinstate a federal requirement that women