Drugs
The Federal Trade Commission (FTC) has sent warning letters to 10 companies and notified FDA it is challenging more than 300 patents across 20 different brand name products listed by the companies in the FDA Orange Book. In a statement, FTC says it is disputing the patent listings as improper
Drugs
FDA has issued a safety alert on the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines (azathioprine, 6-mercaptopurine, and 6-thioguanine), immunosuppressants with a known risk of hepatotoxicity and currently labeled about the risk of fetal harm when used during pregnancy. “Pregnant patients
Drugs
The CDER Office of New Drugs (OND) says it was involved in 55 novel drug approvals in 2023. The approvals are one of the OND successes listed in its 2023 Annual Report. Other report highlights are: * 25 public advisory committee meetings; * over 3,400 formal meetings with drug development program
Drugs
FDA has approved an X4 Pharmaceuticals NDA for Xolremdi (mavorixafor) and its use in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes. The rare genetic disease syndrome causes the body’s immune system
Drugs
FDA is making available a draft guidance entitled “Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.” The document describes best practices for writing composition statements and corresponding statements of ingredients in drug labeling submissions. It includes examples of common, recurring problems
Drugs
FDA has approved Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for treating adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. “Beqvez is a one-time treatment
Drugs
FDA has granted fast track designation for Compass Therapeutics’ CTX-009 in combination with paclitaxel in a Phase 2 study to treat patients with metastatic or locally advanced biliary tract tumors that have been previously treated. The company says CTX-009 is a bispecific antibody that simultaneously blocks Delta-like
Drugs
FDA has published a draft guidance, Cancer Clinical Trial Eligibility Criteria: Washout Period and Concomitant Medicines, part of a series of guidances with recommendations about eligibility criteria for clinical trials of investigational drugs or biologics regulated by CDER or CBER to treat cancer. This document specifically has recommendations about the
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Fresenius Medical Care is recalling (Class 1) its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters to correct the instructions for use on the devices after non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) leaching was found in their peroxide-cross linked silicone tubing. “These NDL-PCBA
Drugs
FDA has published a draft guidance, Cancer Trial Eligibility Criteria: Performance Status, with recommendations for expanding eligibility criteria to include patients with a wide range of performance status in clinical trials of investigational cancer drugs regulated by CDER and CBER. The document is one in a series of guidances with
Drugs
FDA has published a draft guidance, Cancer Clinical Trial Eligibility Criteria: Laboratory Values, with recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants. The document is one in a series of guidances that have recommendations about eligibility for clinical trials of
Drugs
Dr. Reddy’s Laboratories is recalling six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to powder discoloration in some packets that has led to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints, a recall notice says. The drug
Drugs
FDA has approved Utility Therapeutics’ Pivya (pivmecillinam) tablets to treat female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. An agency announcement says Pivya’s efficacy for its indication was assessed in three trials comparing different dosing regimens to placebo,
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Boehringer Ingelheim says an FDA draft guidance on key information and facilitating understanding in informed consent could better emphasize the use of plain language with more specific examples and techniques to ensure understanding across diverse patient populations. The company’s comment letter also calls for: * highlighting more prominently the use
Drugs
Healthy Women, an educational resource for women ages 35-64, is calling on FDA to revise the labeling for all fenofibrate drugs to “remedy the widespread misimpression among healthcare professionals that fenofibrates, when used alone or in combination with statins, reduce cardiovascular risk, and the resulting pervasive, improper use of
Drugs
FDA has approved an Amneal Pharmaceuticals ANDA for a generic over-the-counter naloxone hydrochloride nasal spray, 4mg, (generic Narcan) for treating a drug overdose from opioids, including heroin, fentanyl and prescription opioid medications. The nasal spray is designed to rapidly reverse the effects of a life-threatening opioid emergency
Drugs
Sen. Bernie Sanders (I-VT), chairman of the Senate HELP Committee, says the committee is calling on Novo Nordisk to significantly reduce the cost of its Ozempic (semaglutide) and Wegovy (semaglutide) in the United States. He says the committee has opened an investigation into the “outrageously high prices that Novo
Drugs
An FDA inspection conducted 4/15-4/23 at Zydus Lifesciences’ injectable manufacturing site in Jarod, India resulted in a 10-observation Form FDA-483, according to a company financial release. “The company will closely work with the U.S. FDA to address and respond to the observations in an
Drugs
Three Alston Bird attorneys say there are several steps companies regulated by FDA should take to engage with the agency on its artificial intelligence/machine learning (AI/ML) regulatory activities. Writing in their firm’s FDA/Food, Drug, & Device Advisory, the three say companies should: * review and comment on
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FDA has approved an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The therapy stimulates memory T cells, “leading to long duration of complete response
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FDA says that applicants completed or released most of the postmarketing reports/postmarketing commitments (PMRs/PMCs) for the previous years reported on in the agency’s FY 2022 report on PMR/PMC status. The majority of PMRs/PMCs are progressing according to the original schedule, it says, and overall few
Drugs
Endo’s Par Pharmaceutical is recalling seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone particulates in the product solution. “Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material,” a