Biologics
FDA has granted breakthrough designation for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate to prevent lower respiratory tract disease caused by RSV in individuals age 60 and older. The company says the designation was primarily informed by the positive results of a proof-of-concept Phase 2a study evaluating
Drugs
FDA has approved a label update for Janssen’s Cabenuva (cabotegravir and rilpivirine) to give healthcare professionals and HIV patients the option to start its monthly or every-two-month injectable treatment without the need for an oral lead-in phase of daily Cabenuva tablets for one month. A company
Drugs
FDA has issued Eli Lilly and Innovent Biologics a complete response letter on its BLA for sintilimab injection, a me-too PD-1 inhibitor for use in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC). The letter
Drugs
The CDER/Small Business and Industry Assistance Generic Drugs Forum 2022 will be held 4/26-4/27 with the theme “The Current State of Generic Drugs.” A conference notice says the two keynote speakers will be CDER Office of Generic Drugs director Sally Choe and Office of Pharmaceutical Quality
Drugs
FDA approved 3/23 Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. An agency notice says concurrent approval was granted for the company’
Drugs
An Associated Press report on an upcoming advisory committee meeting to consider Amylyx Pharmaceuticals’ investigational amyotrophic lateral sclerosis (ALS) drug says the drug may cause the agency issues similar to those caused by its controversial approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease. Three advisory committee members
Drugs
PharmaTher says topline results from a dose-finding and tolerability clinical study of ketamine for treating levodopa-induced dyskinesia (LID) in Parkinson’s patients were sufficient for the company to engage FDA to establish next steps for a planned Phase 3 study to allow for ketamine’s approval under the
Drugs
A presentation by CDER Office of Manufacturing Quality branch chief Maan Abduldayem at the 46th Annual International GMP Conference in Athens, GA 3/8 provided the Center’s “Top Recent Warning Letter Citations” (FY 2019 to FY 2021). They are: * CFR 211.192 Production record review (cited in 61 Warning
FDA Policy/General
Federal Register notice: FDA has renewed its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the 3/23/2024. To view the notice, click here.
Devices
FDA has cleared an Artio Medical 510(k) for its Solus Gold Embolization Device for peripheral vascular occlusion. The company says the Solus device offers advantages over current occlusion devices and their difficulties being positioned in challenging anatomies, which often require multiple implants. “The Solus Gold device aims to overcome
Drugs
FDA has issued a complete response letter for the Takeda Natpara (parathyroid hormone) prior approval supplement submitted in 8/2021 to address the potential for rubber particulate formation that led to a U.S. Natpara recall in 9/2019. The company says FDA indicated it could not approve the supplement
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4.” The document describes FDA’s compliance policy regarding requirements that are now applicable to ophthalmic drugs packaged with eye cups, eye droppers, and other dispensers intended for ophthalmic
FDA Policy/General
Federal Register notice: FDA is amending the standing advisory committees’ regulations to change the name and function of the Bone, Reproductive and Urologic Drugs Advisory Committee to Obstetrics, Reproductive and Urologic Drugs Advisory Committee. To view the notice, click here.
Drugs
FDA says Pfizer is recalling six lots of Accuretic (quinapril HCl/hydrochlorothiazide) tablets, one lot of quinapril and hydrochlorothiazide tablets distributed as an authorized generic by Greenstone, and four lots of quinapril HCl/hydrochlorothiazide tablets also distributed by Greenstone. The recalls are due to the presence of a nitrosamine, N-
Drugs
FDA is warning ECI Pharmaceuticals, Fort Lauderdale, FL, about violations in information the company provided to the agency’s electronic drug registration and listing system. A just-released 2/3 Warning Letter says the firm selected an incorrect active ingredient, conjugated estrogens, to be listed in the electronic file for
Drugs
CDER Office of Policy for Pharmaceutical Quality director Ashley Boam is urging pharmaceutical manufacturers to use recommendations contained in the 5/2021 draft guidance “ICH Q12: Implementation Considerations for FDA-Regulated Products” for evaluating chemistry, manufacturing and control (CMC) change reporting requirements. Boam offered this advice during a presentation at
Drugs
FDA says Adamis Pharmaceuticals is recalling four lots of Symjepi (epinephrine) injection distributed in the U.S. by US WorldMeds due to potential clogging of the needle preventing dispensing of the drug. A company 3/21 announcement says Symjepi is indicated for the emergency treatment of allergic reactions (Type 1)
Biologics
Moderna says it will ask FDA for an emergency use authorization (EUA) for its mRNA-1273 Covid-19 vaccine dosed for children 6 months to under 6 years old. The company says it also has started a submission with FDA for a Covid-19 vaccine EUA for children 6 to
Devices
A 9/15-9/26/21 FDA inspection at Unimicro Medical Systems-Shenzhen Co., Shenzhen, China, found Quality System Regulation violations in the firm’s manufacturing of Veress pneumoperitoneum needles. A just-released 1/6 Warning Letter says specific violations were: * failing to adequately establish and maintain procedures to control
FDA Policy/General
Federal Register notice: FDA has announced a 4/6 Vaccines and Related Biological Products Advisory Committee meeting to discuss considerations for use of Covid–19 vaccine booster doses and the process for Covid–19 vaccine strain selection to address current and emerging variants. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued an order debarring Irfanali Nisarali Momin for five years from importing or offering for import any drug into the U.S. The debarment is based on Momin’s felony conviction for illegally importing misbranded drugs from China that he marketed for male enhancement. To
Drugs
FDA has denied a 10/21/21 petition submitted by BioDelivery Sciences International, Raleigh, NC, asking the agency to take certain actions on applications for follow-on buprenorphine buccal film products. Specifically, the petition asked that the agency: * require any applicant for a low or high pH buprenorphine buccal film