Drugs
FDA has sent Evoke Pharma a multi-disciplinary review letter on its 505(b)(2) NDA for Gimoti (metoclopramide), a nasal spray indicated for treating gastroparesis. The letter, according to Evoke, identifies three NDA sections with deficiencies and concerns. These incude: Chemistry (combination product quality control and reproducibility specific to
Drugs
Intellipharmaceutics International has resubmitted an NDA for its oxycodone ER product candidate, indicated for treating pain. In 2018, FDA issued Intellipharmaceutics a complete response letter on the NDA that provided certain recommendations and requests for information, including that it complete the relevant Category 2 and Category 3 studies to assess
Drugs
Novartis has filed a Lanham Act suit in Washington, DC federal court against Janssen seeking to stop it from making false and misleading claims associated with Janssen’s Tremfya, indicated for treating moderate to severe plaque psoriasis. Novartis manufacturers and markets a competing product, Cosentyx. The Novartis lawsuit claims that
Drugs
Former Insys Therapeutics sales vice president Alec Burlakoff testified in Boston federal court last week on how he followed orders to recruit physician and pay illegal kickbacks to increase the sales of addictive Subsys, a fentanyl-based pain drug. It is the first federal trial involving executives of an opioid
Drugs
CDER Office of Prescription Drug Promotion (OPDP) has cited Phoenix Molecular Imaging Center for promoting an investigational drug, 11C-acetate, as safe and effective on a Web page touting prostate cancer imaging. “Your Web page describes 11C-Acetate as a useful PET scan agent for detecting recurrent prostate cancer,” a
Devices
FDA has cleared an eNeura 510(k) for its single-pulse Transcranial Magnetic Stimulation (sTMS) device and expanded use in acute and preventive treatment of migraine to include children 12 years of age and older. The company received clearance for acute and preventive treatment of migraine in adults in 2017.
Biologics
FDA has agreed to accept a CytoDyn rolling BLA submission for PRO 140 (leronlimab), a CCR5 antagonist, indicated for blocking HIV-1 from entering and infecting immune cells. Previously, the agency granted a fast track designation for leronlimab as a combination therapy with highly active antiretroviral therapy for HIV-infected
Devices
FDA has cleared a Safe Medical Design 510(k) for the Signal Catheter, a urinary catheter that is designed to reduce urethral trauma caused by premature balloon inflation during placement. The company says that there are 30 million urethral catheters annually used in the U.S., with up to 500,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Financial Disclosure by Clinical Investigators” (OMB Control Number 0910-0396). To view the notice, click here.
FDA Policy/General
Comments Sought on Cannabis Scheduling Recommendations Federal Register notice: FDA seeks comments on World Health Organization recommendations to impose international manufacturing and distributing restrictions on certain cannabis drug substances. 03/01/2019 Comments Sought on Fentanyl Scheduling Recommendations Federal Register notice: FDA is seeking comments on World Health Organization drug
FDA Policy/General
DEVICES FDA has approved a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants. Approval was based on data from the INSPIRE Trial, the first and largest controlled clinical organ preservation trial in lung transplantation that was conducted at 21 leading international academic
Drugs
FDA has issued a final guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The document addresses the agency’s policies for developing a list of bulk drug substances that can be used in compounding. It
FDA Policy/General
Federal Register notice: FDA is seeking comments on World Health Organization recommendations to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The international drug scheduling recommendations apply to: Dronabinol (delta-9-tetrahydrocannabinol) and its stereoisomers; cannabis, cannabis resin, extracts and tinctures; cannabidiol preparations; and pharmaceutical
Drugs
The FTC has reached a settlement in FTC v. Actavis, a 2009 case alleging that Solvay and three generic drug companies illegally agreed to restrict generic competition to Solvay’s branded testosterone-replacement drug AndroGel for nine years. The settlement covers those products that Solvay may have been marketing or
FDA Policy/General
Federal Register notice: FDA is seeking comments on World Health Organization drug scheduling recommendations on certain narcotic drugs. The international drug scheduling recommendations apply to: Cyclopropyl fentanyl; methoxyacetyl fentanyl; ortho-fluorofentanyl; para-fluorobutyrfentanyl; n-ethylnorpentylone; and four additional substances. To view the notice, click here.
Drugs
AurobindoPharma has expanded a 12/2018 recall to include 38 lots of valsartan and amlodipine and valsartan tablets after detecting trace amounts of a human carcinogen in the finished drug product. The impurity detected is N-nitrosodiethylamine, which is a substance that occurs naturally in certain foods, drinking water, air
Drugs
FDA has issued a Warning Letter to CanaRx for causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers. The letter outlines the company’s “scheme” to contract with public and private entities to provide prescription drug coverage to their employees. “In the scheme, CanaRx facilitates
Drugs
Pulse Biosciences has submitted a 510(k) for the CellFX System for use in common dermatologic procedures to remove general benign lesions including sebaceous hyperplasia, a common but difficult to treat facial lesion and seborrheic keratosis, the most common benign raised pigmented lesion. The device uses “non-thermal delivery of
Drugs
FDA has approved an Adlon Therapeutics 505(b)(2) NDA for Adhansia XR (methylphenidate hydrochloride) extended-release capsules for treating attention-deficit/hyperactivity disorder in patients six years and older. In a simulated adult workplace environment study, Adhansia XR demonstrated statistically significant improvement over placebo at 1, 2, 5, 8,
Biologics
FDA officials say the agency lacks the resources needed to pursue a comprehensive crackdown on the growing private stem cell industry. Responding to a lengthy Washington Post investigative report reviewing cases of several people who have been hospitalized after being injected with products made from umbilical cord blood, FDA commissioner
Devices
FDA has issued a safety alert on using robotically-assisted surgical devices in women’s health procedures, including mastectomy and other cancer-related surgeries. The alert says that the safety and effectiveness of these devices in such cases has not been established. “There is limited, preliminary evidence that the use
Drugs
FDA has approved a Janssen Pharmaceutical supplemental BLA for Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. The company says One-Press offers a controlled injection that hides the needle throughout the process. Approval was based on results from the