Drugs
FDA says its testing of Herbacil Antiseptic Hand Sanitizer produced by Broncolin, Iztacalco, Mexico, found that the product is adulterated and misbranded. A 12/21 Warning Letter says agency laboratory testing determined that the product contained large amounts of methanol, even though it was labeled to contain ethanol. The letter
Drugs
FDA says Sunstar Americas has expanded its nationwide recall of Paroex chlorhexidine gluconate oral rinse 0.12% due to microbial contamination. The expanded recall covers products bearing an expiration date from 12/31/20 to 9/30/22, according to an agency notice. The notice says the product may be
Drugs
FDA has approved Ridgeback Biotherapeutics’ Ebanga (ansuvimab-zykl), a human monoclonal antibody, to treat Zaire ebolavirus infection in adults and children. An agency notice says Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell. The agency says that Zaire ebolavirus is one of
Drugs
FDA says it has taken steps to strengthen the Risk Evaluation and Mitigation Strategies (REMS) program for transmucosal immediate-release fentanyl (TIRF) products to help ensure that the drugs’ benefits continue to outweigh their risks. An agency statement says that despite the decline in the use of TIRF products in
Drugs
FDA has published a guidance, Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling, to describe the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of
Drugs
FDA has published a guidance, Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment is Needed During the Covid-19 Public Health Emergency, with information on review timelines the agency will use during the Covid-19 public health emergency. The document applies to applicant responses to
Drugs
FDA has published a guidance, Consumer Antiseptic Final Rule Questions and Answers, to help small businesses understand and comply with the antiseptic rub final rule that applies to active ingredients used in over-the-counter (OTC) consumer antiseptic rub products, sometimes referred to as rubs, leave-on products, or hand
Drugs
Washington Legal Foundation (WLF) has submitted an amicus brief urging the 7th Circuit Court of Appeals to affirm an Illinois federal court decision in a case involving drug patents under antitrust law. A WLF statement says UCFW Local 1500 Welfare Fund v. AbbVie challenges a settlement between AbbVie and several
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to withdraw its 9/24/20 Request for Proposals (RFP) Regarding Insulin Reimportation Programs. A 12/17/20 petition also calls on the agency to: * refrain from reimportation of insulin under section 801(d)(2) of the Federal Food,
Drugs
FDA has published a draft guidance, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations, to help sponsor-investigators develop such drug products for a severely debilitating or life-threatening genetic disease. The document focuses on the administrative and procedural aspects of interacting with FDA on development
Drugs
Despite challenges from balancing resources to navigate the Covid-19 pandemic, FDA approved 53 new molecular entities in 2020, which is five (10%) more than it approved in 2019 and six shy of 2018’s record 59 approvals. A quick look at the approvals shows that many were for treating
Drugs
FDA has released a draft guidance entitled Dry Eye: Developing Drugs for Treatment that is intended to provide recommendations to sponsors about eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and greater efficiency in development programs for such drugs. It recommends both traditional environmental
Drugs
FDA has approved Myovant Sciences’ Orgovyx (relugolix) for treating adult patients with advanced prostate cancer. “Today's approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” FDA Oncology
Drugs
FDA is continuing to explore using “remote regulatory assessments” in lieu of conducting physical facility inspections during the Covid-19 public health emergency, according to CDER Office of Compliance director Donald Ashley. Speaking during a virtual Food and Drug Law Institute conference 12/16, Ashley discussed how CDER has adapted
Drugs
Biogen has agreed to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two foundations, Chronic Disease Fund (CDF) and The Assistance Fund (TAF), as conduits to pay Medicare co-pays for patients taking the company’s multiple sclerosis drugs, Avonex and Tysabri.
Drugs
FDA has posted an updated List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic. The agency says the list includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of the update and for which the agency has not approved an
Drugs
FDA says its review of Web and social media sites maintained by Phoenix Biotechnology and Avila Herbals, San Antonio, TX, indicate that the companies are marketing an Oleander 4X product manufactured by Avila for Phoenix and intended to mitigate, prevent, treat, diagnose, or cure serious and/or life-threatening conditions
Drugs
Parenteral Technologies is petitioning FDA to amend the children’s over-the-counter dosage schedule and directions of single-ingredient acetaminophen for ages 2-4 as published in the 11/16/88 tentative final monograph. The 11/21 petition also asks the agency to publish a statement of enforcement policy
Drugs
FDA is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk. An agency statement says FDA purchased the products on Amazon and eBay and then tested them. It reports finding that
Drugs
FDA has approved MacroGenic’s Margenza (margetuximab-cmkb), in combination with chemotherapy, to treat adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. A company statement says Margenza is the first HER2-
Drugs
FDA has accepted for priority review a Takeda Pharmaceutical NDA for Eohilia (budesonide oral suspension) for treating eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus. The NDA is based on data from the pivotal Phase 3 trials ORBIT1 and ORBIT2, which investigated the safety
Drugs
FDA has published a guidance, Controlled Correspondence Related to Generic Drug Development, with information on the process by which generic drug manufacturers and related industry or their representatives can submit controlled correspondence to FDFa requesting information related to generic drug development. The document also describes the agency's process