FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Evofem Biosciences direct-to-consumer brochure for its Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel overstates the expected benefits associated with using the product. A 10/31 Untitled Letter says the brochure makes false and misleading claims
Drugs
FDA has approved a Takeda Pharmaceuticals NDA for Fruzaqla (fruquintinib) for use in adult patients suffering from metastatic colorectal cancer (mCRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if medically appropriate and RAS wild-type, an anti-EGFR therapy. Approval is based
Drugs
FDA revised 11/7 the existing indication of Merck’s Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinomas. An agency post says the updated indication, which remains approved under
Devices
FDA has cleared an ACON Laboratories 510(k) for its Flowflex Covid-19 Antigen Home Test, which was originally authorized for emergency use in 2021. According to an FDA news release, Flowflex is the second home Covid-19 test to successfully complete a traditional FDA premarket review pathway. Notably, it
FDA Policy/General
Federal Register notice: FDA is classifying the container system for the processing and storage of red blood cell components under reduced oxygen conditions into Class 2 (special controls). To view the notice, click here.
Biologics
FDA has approved Takeda’s Adzynma, a recombinant protein product designed for prophylactic or on‑demand enzyme replacement therapy (ERT) in both adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) — a rare life-threatening blood clotting disorder. cTTP is linked to a disease-causing mutation in the ADAMTS13
Drugs
The CDER Office of Therapeutic Biologics and Biosimilars (OTBB) has recommended a determination that the first interchangeable exclusivity (FIE) expired on 4/15 for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), 40mg/0.8mL and 20mg/0.4 mL for subcutaneous use, and on 9/18 for Cyltezo injection 10mg/0,
Drugs
FDA has approved an Eli Lilly NDA for Zepbound (tirzepatide) subcutaneous injection for chronic weight management in adults with obesity who are on a reduced calorie diet and an exercise regimen. Tirzepatide, which is already approved under the trade name Mounjaro for treating Type 2 diabetes, is intended for use
Biologics
CBER director Peter Marks and researchers from three academic medical centers say that registries used in the U.S. and several other countries to track the use of Covid-19 convalescent plasma (CP) showed that CP was effective when used early and with high titer. Writing in an mBio editorial,
Drugs
Organon says it agrees with a proposal in an FDA 9/18 draft guidance on biosimilar labeling that both biosimilars and interchangeables include a biosimilar statement. In a comment letter, the company says it agrees with the agency’s rationale that the interchangeability standard is not likely to be useful
Drugs
Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) have introduced the Protecting Consumer Access to Generic Drugs Act of 2023, which would support access to lower-priced generic prescription drugs. The bill would “end harmful pay-for-delay practices and provide the FTC
FDA Policy/General
Federal Register notice: FDA is making available a guidance entitled “Real-Time Oncology Review (RTOR).” The document provides recommendations to applicants on the process for submitting NDAs and BLAs with oncology indications for review under RTOR. The real-time review program facilitates earlier submission of topline results (i.e., efficacy
Devices
FDA has approved a PMA for Recor Medical’s Paradise ultrasound renal denervation system indicated to treat hypertension. The company says Paradise is intended as an adjunct treatment when lifestyle changes and medications have not adequately controlled a patient’s blood pressure. It is described as a first-of-its-
Devices
Becton Dickinson’s CareFusion unit has recalled (Class 1) its Alaris Patient Controlled Analgesia infusion pump module 8120 because the compatible syringes’ labeling contains syringes that have not been validated. In a recent letter to users, the company told them to stop using certain Cardinal Health-branded Monoject syringes with
Drugs
An 11/7 petition filed by Lassman Law & Policy on behalf of an unnamed client asks FDA not to approve a pending NDA for Amryt Pharma’s Filsuvez (oleogel-S10) to treat cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB) without additional clinical data demonstrating it is safe
FDA Policy/General
Federal Register notice: FDA is making available a guidance entitled “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” The document announces FDA’s intention to delay enforcement of requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the initial
Drugs
After an almost 18-year career at FDA, former FDA reviewer Sarah McGarry has joined consulting firm Greenleaf Health as senior vice president of drug and biological products. “As an infectious disease specialist, Sarah dedicated much of her career to CDER’s antivirals division, where she played a significant role
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Otsuka direct-to-consumer TV ad and computer banner ad for Rexulti (brexpiprazole) tablets make false or misleading claims and representations about the drug’s efficacy. A 10/31 Untitled Letter says the violation is “especially concerning because major depressive
Devices
A 4/4-4/25 FDA inspection at Neurotris, Inc., doing business as A1 Engineering in Irvine, CA, determined the firm manufactures and distributes several unapproved Class 2 powered muscle stimulator devices, sometimes known as the Neurotris Body System. A 10/27 Warning Letter says the firm is illegally marketing
Drugs
FDA has published a guidance, Real-Time Oncology Review, with recommendations to applicants on the process for submitting selected NDAs and BLAs with oncology indications for review under Real-Time Oncology Review (RTOR). The document does not address the agency’s expedited programs and notes that ROTR is separate from
Drugs
Imbria Pharmaceuticals says it is planning a Phase 3 study of ninerafaxstat, a novel cardiac mitotrope and partial fatty acid oxidation inhibitor, in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The move comes as the company is reporting data from its Phase 2 IMPROVE-HCM clinical trial, which it
Drugs
Nurse Assist has recalled 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to the potential for a lack of sterility assurance. The products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol,