Drugs
FDA has published a draft guidance, Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment, with the agency’s current recommendations about developing drugs to support an indication for treating early Lyme disease as manifested by erythema migrans. The document does not contain a discussion of the
Drugs
FDA says IBSA Pharma is recalling select lots of Tirosint-Sol (levothyroxine sodium) oral solution due to subpotency. An agency notice says the company is recalling 27 lots because they may be subpotent. “The company’s analyses show a slight decrease below 95% of its labeled amount in levothyroxine sodium
Drugs
Pfizer says it gained an expanded indication in late December for Ibrance (palbociclib) to include its use in combination with an aromatase inhibitor (AI) for treating HR+/HER2- metastatic breast cancer, regardless of menopausal status — the only CDK 4/6 inhibitor with this indication. “The approval expands on Ibrance’s
Drugs
A 4/11-4/27/22 FDA inspection at Adept Life Science in Chandler, AZ, found “serious violations” of the Federal Food, Drug, and Cosmetic Act and applicable regulations as they apply to dietary supplements. A 1/24 Warning Letter gives eight examples of current good manufacturing practice (CGMP) violations
Drugs
FDA’s 2022 GDUFA Science and Research Report says that during FY 2022 FDA awarded eight new research contracts and seven new grants (not including supplements to existing projects) for innovative extramural research projects relevant to generic drugs. The report says the agency also used its laboratories and computer systems
Drugs
Two FDAers from the CDER Office of Translational Sciences say there is an opportunity to leverage innovations in clinical pharmacology and related disciplines to improve the efficiency of biosimilar development and approval. Writing in an editorial introducing a themed issue of Clinical Pharmacology & Therapeutics, the authors say one way
Drugs
FDA has published a draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products, with recommendations for sponsors and investigators considering the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug product. The document addresses
Drugs
Attorneys James Boiani and Delia Deschaine (Epstein Becker Green) say FDA’s recent Federal Register notice on orphan drug exclusivity (see earlier story) “is a remarkably direct rebuke” of the an 11th Circuit Court of Appeals decision in Catalyst Pharms, “especially in light of Congress’ rejection of legislation that would
Drugs
FDA is making available a draft guidance entitled “Acromegaly: Developing Drugs for Treatment.” The document provides recommendations about the clinical development of such drugs, and the agency says it is intended to serve as the basis for continued discussions with its Division of General Endocrinology, pharmaceutical sponsors, the academic community,
Drugs
The U.S. District Court for Southern Florida 1/20 entered a consent decree of permanent injunction against LGM Pharma and two of the company's executives, CEO Prasad Raje and quality and regulatory affairs senior vice president Shailesh Vengurlekar, to bring the company into CGMP compliance. LGM introduced
Drugs
FDA has extended by three months its review of an Argenx BLA for subcutaneous efgartigimod for treating adult patients with generalized myasthenia gravis. The revised user fee review action target date is 6/20. The agency told the company that recently submitted information constituted a major amendment and requires a
Drugs
Several public health advocacy groups have filed a lawsuit against FDA that challenges a 2021 denial of a citizen petition that sought the withdrawal of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes. The petition included FDA’s own assessment that the antibiotics used
Drugs
Janssen Pharmaceutical says it will seek FDA approval of a planned NDA supplement for Carvykti (ciltacabtagene autoleucel; cilta-cel) after announcing favorable data from its Phase 3 CARTITUDE-4 study evaluating the therapy versus pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients with relapsed and lenalidomide-refractory
Drugs
Vanda Pharmaceuticals has petitioned FDA asking that it immediately revoke the approval of a TEVA ANDA for a generic copy of Vanda’s Hetlioz (tasimelteon) because Teva’s product fails to satisfy the same labeling and same conditions of use requirements. Hetlioz is indicated for treating non-24-hour sleep-
Drugs
FDA has denied a 3/2021 petition filed by Loeb & Loeb on behalf of an unnamed client that asked the agency to take specific actions concerning the adequacy of safety labeling for Incyte’s JAK inhibitor drug Jakafi (ruxolitinib) tablets. The petition asked FDA to open a public docket
Drugs
FDA has granted Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) for treating relapsed or refractory mantle cell lymphoma (MCL) patients who have had at least two lines of systemic therapy, including a BTK inhibitor. Approval was based on data from the BRUIN (NCT03740529) single-arm trial of pirtobrutinib monotherapy in
Drugs
Representative Brett Guthrie (R-KY) has been selected to serve as the House Energy and Commerce Committee’s Health Subcommittee chair for the current 118th Congress. The subcommittee has primary oversight of FDA and other health agencies. “My goal is to have a productive Health Subcommittee this Congress to ultimately
Drugs
FDA principal deputy commissioner Janet Woodcock says the agency has determined that current regulatory pathways are not appropriate for cannabidiol (CBD) products and it will work with Congress on a new cross-agency regulatory framework. In a statement, Woodcock says the need for a new framework was determined by a
Drugs
FDA says AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorized for emergency use against Covid-19 infection in the U.S. until further notice. An agency notice says data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants that are projected to
Drugs
Emergent has recalled certain Reactive Skin Decontamination Lotion (RSDL) kits from a specific batch based on customer complaints about some packets leaking. An FDA recall notice says each kit contains a sponge soaked with lotion, and they are intended for military use to remove or neutralize chemical warfare agents and
Drugs
FDA has told Torrent Pharmaceuticals that a 9/2022 inspection of the company’s India (Indrad, Gujarat) facility has been classified as “Official Action Indicated.” The company says the classification will not have impact on existing supplies or revenues from the facility. “Torrent Pharma continues to cooperate with the USFDA
Drugs
FDA says there is no evidence at this time that contaminated cough syrup products that have killed more than 300 children in Asia and Africa have entered the U.S. supply. CBS News reports the agency gave the assessment while saying it is joining the World Health Organization (WHO) and