Drugs
Pacira BioSciences says it will submit a supplemental NDA early next year to broaden the label for its post-surgical pain drug Exparel (bupivacaine extended-release liposome injection) for use as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee
Biologics
CBER has announced a 10/5 Webinar entitled “Study Data Standards Update for CBER: Your Guide to a Successful Submission” that will discuss the Center’s support and requirement beginning 3/15/2023 for using the Standard for the Exchange of Nonclinical Data (SEND). The one-hour Webinar will discuss
Drugs
FDA has lifted its clinical hold on Sarepta’s SRP-5051 (vesleteplirsen), an investigational, next-generation peptide conjugated phosphorodiamidate morpholino oligomer indicated to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping. The company says that as part of the lift, it will adjust the Phase
Drugs
FDA says its review of a Web site maintained by Leaf of Life, St. Louis, MO, determined that the company takes orders for several dietary supplements that are legally considered to be drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. A just-
Devices
FDA has expanded the approved labeling for Boston Scientific’s Watchman FLX Left Atrial Appendage Closure Device to include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to the previous 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of patients with non-valvular
Drugs
CDER scientists are working on ways to improve the bioavailability of drugs that do not dissolve well in water on their own. An Impact post describes research exploring the potential for using amorphous solid dispersions to formulate generic drug products that may include poorly water-soluble ingredients. “Understanding the supersaturation
Biologics
FDA has issued Alvotech a complete response letter on its biosimilar BLA for AVT02, a monoclonal antibody that was being evaluated for biosimilarity and interchangeability to Abbott’s Humira (adalimumab). The letter cited inspection deficiencies at its Reykjavik, Iceland manufacturing facility, which must be corrected before the therapy can be
Drugs
FDA has denied all but two requests in a 2/15/21 petition submitted by Salix Pharmaceuticals asking that the agency not approve any 505(j) ANDA referencing any strength of Xifaxin (rifaximin) tablets as the reference-listed drug unless one of five specified bioequivalence and pharmaceutical equivalence criteria is
Drugs
The Department of Justice (DoJ) says Bayer has agreed to pay $40 million to resolve two whistleblower suits alleging violations of the False Claims Act in connection with the drugs Trasylol, Avelox, and Baycol. The whistleblower suits were filed and pursued for almost two decades by former Bayer marketing employee
FDA Policy/General
The 2022 Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science report highlights updates to the 2021 report. FDA commissioner Robert Califf says the updates make apparent “the incredible breadth and depth of FDA’s science base.” Califf writes in the report’s introduction that in addition to highlighting
Drugs
FDA has accepted a Bausch & Lomb and Novaliq NDA for NOV03 (perfluorohexyloctane), an eye drop therapy for treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Perfluorohexyloctane is described as a water-free, non-steroidal, single-component preservative-free eye drop. The
Devices
FDA has cleared a Magnus Medical 510(k) for the Saint Neuromodulation System for treating major depressive disorder (MDD) in adults who have failed to achieve satisfactory improvement from prior antidepressant medications. The clearance was based on data from a double-blind, randomized controlled trial that showed “79% of people
Drugs
FDA has approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company says the approval was based on “a review of a comprehensive
Drugs
FDA reviewers appear pessimistic that new analyses and data from Amylyx can push its amyotrophic lateral sclerosis (ALS) drug AMX0035 (sodium phenylbutyrate and taurursodiol) across the approval finish line as the submission heads to a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting. Earlier this year, the
Drugs
FDA has approved a Boehringer Ingelheim NDA for Spevigo (spesolimab) as a treatment option for generalized pustular psoriasis (GPP) flares in adults. The novel, selective antibody is said to work by blocking the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to
Drugs
FDA has approved an Azurity Pharmaceuticals NDA for Konvomep (omeprazole and sodium bicarbonate for oral suspension), a proton pump inhibitor for treating active benign gastric ulcer and reducing risk of upper gastrointestinal bleeding in critically ill patients. Omeprazole and sodium bicarbonate are the active ingredients in Santarus’ Zegerid. “We are
Devices
FDA has granted Vibrant Gastro de novo marketing authorization for its Vibrant, an orally administered drug-free capsule for treating adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month. Vibrant is believed
Drugs
FDA has approved an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for combination use with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. Approval was based on overall survival (OS) and other data from the TOPAZ-1 trial that enrolled 685 patients. “A statistically significant
Drugs
FDA has issued a form FDA-483 to India’s Biocon Biologics following three on-site August inspections at the company’s seven manufacturing sites in Bengaluru, India, and Johor, Malaysia. In a stock exchange notice, Biocon says the inspections were triggered by three preapproval inspections for biosimilar bevacizumab, rh-
Devices
Cue Health has submitted a de novo marketing submission for its Cue Flu Molecular Test for at-home and point-of-care (POC) use. The company says currently there are no flu tests on the market for home use. “Clinical study results with the Cue Flu Molecular Test were favorable,
Drugs
The FY 2021 GDUFA Science and Research Outcomes Report demonstrates that research outcomes have played an increasing role over four years in supporting the development of generic drug products. A chart in the report shows the number of: * pre-ANDA meetings affected by research increased from 62 in FY 2018
Drugs
FDA says it is partnering with the Critical Path Institute (C-Path) to explore the feasibility of launching a Lysosomal Diseases Consortium. An agency post says the consortium would be a public/private partnership among FDA, leading academic institutions, pharmaceutical industries, patient groups, and non-government organizations to address unmet