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
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Quality director Ashley Boam is urging pharmaceutical manufacturers to use recommendations contained in the 5/2021 draft guidance “ICH Q12: Implementation Considerations for FDA-Regulated Products” for evaluating chemistry, manufacturing and control (CMC) change reporting requirements.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)
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
Drugs
Provention Bio has resubmitted its BLA for teplizumab for the delay of clinical Type 1 diabetes (T1D) in at-risk individuals. The agency has set an 8/17 user fee review action target date. In 7/2021, FDA issued a complete response letter stating that a single, low-dose pharmacokinetic/
Drugs
FDA has approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw), described as a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a fixed-dose intravenous infusion, for treating adult and pediatric patients age 12 and older with unresectable or metastatic melanoma. The company
Drugs
The Association for Accessible Medicines (AAM) says there are steps the Federal Trade Commission and Department of Justice could take to modernize the enforcement of antitrust laws regarding mergers. In its 3/21 response to the agencies’ 1/18 request for information, AAM addresses the anticompetitive challenges caused by merger
Drugs
Federal Register notice: FDA has announced an Emergency Use Authorization issuance to Eli Lilly for bebtelovimab and its use in treating mild-to-moderate Covid-19 in certain adults and pediatric patients who are at high-risk for progression to severe disease, including hospitalization or death. To view the notice,
Drugs
FDA has published an immediately-in-effect guidance, Certain Ophthalmic Products: Regarding Compliance with 21 CFR Part 4, with information on compliance with the regulatory requirements for ophthalmic drugs packaged with eyecups, eye droppers, or other dispensers. The document says FDA was issuing it without advance time for comments because
Drugs
FDA has posted a Cadila Healthcare (a Zydus Lifesciences company) Form FDA-483 that provides details of GMP violations identified in a 3/10 FDA Webview story. For example, during FDA’s inspection of the firm’s Jarod, Gujarat (India) injectable facility between 2/24 and 3/10, the 483
Drugs
AstraZeneca says new preclinical authentic “live” virus data from Washington University School of Medicine demonstrated that the company’s Evusheld (tixagevimab co-packaged with cilgavimab) “retains potent neutralizing activity against the emerging and highly transmissible Omicron SARS-CoV-2 BA.2 subvariant. The data also showed that Evusheld retains activity
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for treating patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test. The therapy is indicated for those who have disease progression following prior systemic therapy in any setting
Drugs
DEVICES FDA has cleared a Hologic 510(k) for the Cynosure body contouring product, SculpSure, to treat the back and inner and outer thighs. The SculpSure treatment is already FDA-cleared for treating abdomen and love handles (flanks). Hologic says the device uses a selective wavelength laser to precisely target
Drugs
FDA has approved Corium’s Adlarity (donepezil transdermal system) to treat patients with mild, moderate, or severe dementia of the Alzheimer’s type. The company says it is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood
Drugs
The drug industry lobbying arm Pharmaceutical Research and Manufacturers of America told a House Energy and Commerce Committee hearing 3/17 that proposed reforms to the accelerated approval program are not needed and that it is concerned with any FDA-related policy proposals and legislative riders being added to negotiated
Drugs
Merck says new data from the pivotal Phase 3 KEYNOTE-091 trial found that adjuvant treatment with Keytruda significantly improved disease-free survival (DFS), one of the dual primary endpoints, reducing the risk of disease recurrence or death by 24% compared to placebo in patients with stage IB to IIIA
Drugs
FDA says its reviews of a Web site and social media sites maintained by Iotech International, Boca Raton, FL, determined that the company is selling ioRinse and ioCleanse in the U.S., saying they are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 3/15
Drugs
FDA has approved Marinus Pharmaceuticals’ Ztalmy (ganaxolone) oral suspension to treat seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy in patients age 2 and older. The company says it is the first FDA-approved treatment specifically in CDD. Ztalmy’s approval
Drugs
An FDA analysis finds a first-cycle approval rate of 13% for modified release tablet ANDAs submitted between 2017 and 2019. “Deficiencies identified in multiple review disciplines are responsible for the low first-cycle approval rate,” a CDER chart says. “Most of the cited manufacturing process-related deficiencies are unit
Biologics
There are several decisions facing new FDA commissioner Robert Califf over the next few months that will give insight into his thinking, according to a Barron’s article (subscription required). The article identifies and describes these issues: * Amylyx Pharmaceuticals’ experimental ALS therapy AMX0035 could put the agency into another Biogen