Drugs
CDER says a recently published meta-analysis of progestogen use to reduce pre-term birth (PTB) risk is not persuasive and will not change its course to withdraw Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate injection) from the market. Late last year, FDA proposed a rare product approval reversal for Makena because
Drugs
FDA has accepted for priority review a Mirum Pharmaceuticals NDA for maralixibat, an oral apical sodium dependent bile acid transporter inhibitor for treating cholestatic pruritus in patients with Alagille syndrome, a rare liver disease for which there are currently no approved therapies. The company says the drug works by inhibiting
Biologics
FDA has approved a Celgene BLA for Abecma (idecabtagene vicleucel), a cell-based gene therapy for treating adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines of therapy. The agency says this is the first cell-based gene
Drugs
FDA has approved an Astellas Pharma NDA for Myrbetriq (mirabegron extended-release tablets) for treating neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules (mirabegron for extended-release oral suspension) for treating NDO in pediatric patients aged three
Devices
FDA has granted a de novo marketing authorization for Helius Medical’s Portable Neuromodulation Stimulator, indicated for use as a short-term treatment for gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The neuromuscular tongue stimulator comprises a non-implantable apparatus to generate electrical pulses for
Biologics
FDA has issued Merck a complete response letter on a supplemental BLA for Keytruda, the company’s anti-PD-1 therapy for treating patients with high-risk early-stage triple-negative breast cancer, in combination with chemotherapy as pre-operative treatment, and then continuing as a single agent as post-
FDA Policy/General
7 No-Longer-Marketed ANDAs Withdrawn 03/25/2021 Federal Register notice: FDA is withdrawing approval of seven ANDAs from multiple applicants after they notified the agency that the drug products are no longer marketed and requested that they be withdrawn. To view the notice, click here. Info Collection on
Devices
CDRH’s Covid-19 experience with diagnostics will lay the foundation to expand home testing for routine medical care and future outbreaks. Writing in the 3/22 Health Affairs Blog, CDRH director Jeff Shuren and Office of In Vitro Diagnostics and Radiological Health director Tim Stenzel say progress in advancing
FDA Policy/General
Federal Register notice: FDA is announcing the user fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for fiscal year 2021. The fee for a OTC Monograph Order Request Tier 1 is $500,000 and Tier 2 is $100,000. Tier 1 requests include new OTC
FDA Policy/General
Federal Register notice: FDA has announced a 5/6 Arthritis Advisory Committee meeting. Panel members are scheduled to discuss a ChemoCentryx NDA for avacopan oral capsules, indicated for treating anti-neutrophil cytoplasmic antibody-associated vasculitis. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is issuing an order to debar Ursula Wing for a period of five years from importing or offering for import any drug into the U.S. FDA bases the order on a finding that she was convicted of one felony count under federal law related to
FDA Policy/General
Federal Register notice: FDA is publishing a list of seven information collections that have been approved by OMB. They are: * Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies * Orphan Drugs * Electronic Records: Electronic Signatures * Extra Label Drug Use in Animals * Reporting and Recordkeeping Requirements for Human Food and Cosmetics
FDA Policy/General
Federal Register notice: FDA has issued an order to debar for 10 years Thomas J. Whalen from importing or offering for import any drug into the U.S. FDA based this action on his conviction related to importing and distributing misbranded and non-FDA-approved injectable drugs. To view the
Drugs
A wave of negative drug approval news has left industry and financial analysts wondering if FDA has raised the bar on drug approvals, but FDA dismisses the concern, claiming it is business as usual. Over the past few months, some high-profile drug reviews have hit snags and FDA watchers
Devices
FDA has approved a Medtronic PMA for its Harmony Transcatheter Pulmonary Valve (TPV), the first minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle that makes it difficult for blood to travel from the heart to the lungs. The company
Drugs
FDA says it is asking all manufacturers of over-the-counter Benzedrex (propylhexedrine) decongestant inhalers to consider product design changes that support safe use. The request is included in an agency drug safety communication that warns that abuse and misuse of the inhaler can lead to serious harm such as
Drugs
Alembic Pharmaceuticals has recalled one lot of telmisartan tablets, USP, 20 mg, packaged in 30-count bottles (Lot # 1905005661) due to a mislabeling concern. The company says it received a complaint that one bottle labeled as 30-count telmisartan tablets 20mg incorrectly contained 30 tablets of telmisartan tablets 40mg. Patients
Biologics
AstraZeneca has lowered its Covid-19 clinical trial vaccine efficacy rate from 79% to 76% after conducting a “primary analysis” following a data and safety monitoring board concern that the company may have included outdated information (see story) in releasing information earlier this week.“ The primary analysis is pre-specified
Drugs
The Critical Path Institute (C-Path) is joining the CDER Office of Translational Science and the Division of Cardiology and Nephrology in an Acute Kidney Injury (AKI) Project to develop a suite of prognostic tools to improve the prediction and detection of drug-induced kidney injury (DIKI). A C-Path
Drugs
FDA is republishing fee rates for the over-the-counter (OTC) monograph drug user fee program. A Federal Register notice says the rates were authorized under the 3/2020 Coronavirus Aid, Relief, and Economic Security Act to support the modernization of the OTC monograph program. After the fees were initially
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for CVRx’s Barostim Neo, indicated for improving symptoms of heart failure, quality of life, six-minute hall walk and functional status for patients who remain symptomatic despite treatment with guideline-directed medical therapy. The regulatory
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that discuss the design of bioequivalence studies to support ANDAs. To view the notice, click here.