Drugs
FDA has approved Pfizer’s Prevnar 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine for use in infants and children aged six weeks through 17 years. It is also approved for preventing otitis
Drugs
Teva Pharmaceuticals has recalled 13 lots of various strengths of fentanyl buccal tablets due to safety updates that were omitted in the product insert/medication guide materials that are provided with the affected lots. Teva manufactured and labeled the products exclusively for Mayne Pharma, a recall notice says. The notice
Drugs
FDA has approved an Otsuka America Pharmaceutical and Lundbeck NDA for Abilify Asimtufii (aripiprazole) a once-every-two-months injection for treating schizophrenia in adults or for maintenance monotherapy treatment of Bipolar I disorder in adults. The companies note that the extended-release intramuscular injectable suspension is not approved for
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) is planning to research issues related to using endorsers in direct-to-consumer TV ads for prescription drugs. A Federal Register notice says the research will examine the influence of two independent variables — endorser type (patient or doctor) and actual-use disclosure
Drugs
Eli Lilly says that following positive results from the Phase 3 SURMOUNT-2 trial, it plans to complete in coming weeks an FDA submission for its tirzepatide in adults with obesity or overweight with weight-related comorbidities. A company statement says tirzepatide achieved up to 15.7% weight loss in
Drugs
The Better Business Bureau’s National Advertising Division (NAD) has sent superiority claims made in ads for ViiV’s HIV drug Dovato (dolutegravir/lamivudine) to FDA and the Federal Trade Commission for review after the company declined to participate in an NAD self-regulatory process on the claims. The NAD
Drugs
Bipartisan legislation to make the U.S. pharmaceutical supply chain less dependent on China and other foreign countries has been reintroduced by Reps. Earl Carter (R-GA), Darren Soto (D-FL), Carol Miller (R-WV), and Matt Cartwright (D-PA). A statement (includes a link to the bill text) issued
Drugs
FDA has approved a Seres Therapeutics BLA for Vowst (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based product to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). The product is not indicated for treating CDI, according
Drugs
Public Citizen has petitioned FDA to promptly add Covis Pharma’s Makena (hydroxyprogesterone caproate) and its generics to the official list of drugs withdrawn or removed from the market because they were deemed unsafe or ineffective. A statement (contains a link to the petition) says the action is necessary to
Drugs
Rep. Kirsten Gillibrand (D-NY) has introduced bipartisan legislation to expedite provisional FDA approval of drugs intended to treat ALS (amyotrophic lateral sclerosis), Parkinson’s, Alzheimer’s, and other life-threatening illnesses. In a statement, Gillibrand says the standard FDA approval process takes many years to get drugs to market,
Drugs
A Parenteral Drug Association (PDA) online post says discussion with industry members demonstrates ongoing concerns about CDER’s Quality Management Maturity (QMM) program that was approved at an 11/2-11/3/22 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The post says QMM is intended to
Drugs
FDA has cleared two 510(k)s from 3M Health Care for its 3M Veraflo Cleanse Choice Complete Dressing and 3M VAC Veraflo Cleanse Choice Dressing, which the company describes as negative pressure wound therapies. 3M says the dressings received the first-ever clearance for hydromechanical removal of infectious materials,
Drugs
CorMedix says that following a meeting with FDA, it plans to resubmit its NDA for DefenCath by mid-May. A company statement says that at the meeting, FDA indicated it had received the close-out report for inspectional observations at the CorMedix contract manufacturing organization and the NDA could be
Drugs
Harvard Medical School researchers say real-world evidence studies can reach similar conclusions as randomized clinical trials (RCT) when design and measurements can be closely emulated, although such emulation may be difficult to achieve. Writing in the Journal of the American Medical Association, the researchers say they emulated the design
Drugs
With positive results from the Phase 3 APPOINT-PNH trial showing that the investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels in treatment-naïve paroxysmal nocturnal hemoglobinuria (PNH) patients, Novartis says it is planning global regulatory submissions, including FDA, in the first half of this year. The company
Drugs
FDA has released the form FDA-483 issued following a 3/6-3/17 inspection at Alvotech Hf, a Reykjavik, Iceland, drug substance and drug product manufacturer. The eight inspection observations were: * failing to have in writing and fully follow the responsibilities and procedures applicable to the quality unit; * failing
Drugs
Akorn (Gurnee, IL) through its bankruptcy (Chapter 7) trustee is recalling various within-expiry human and animal products because the company has ceased all operations, including quality activities. In February, Akorn announced that it failed to find a buyer for its operations and terminated all employees (see letter). “The discontinuation
Drugs
FDA has approved a Vertex Pharmaceuticals supplemental NDA for the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor) to include children with cystic fibrosis (CF) aged two through five years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the
Drugs
FDA is asking the Oncologic Drugs Advisory Committee (ODAC) to discuss whether an sNDA for AstraZeneca’s olaparib (Lynparza) should be restricted to selected patients. An agency briefing document released in advance of the 4/28 ODAC meeting says AZ is seeking a broad indication for olaparib in combination with
Drugs
An 11/6-11/10/22 FDA inspection at the Pharmaplast drug manufacturing facility in Alexandria, Egypt, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/13 Warning Letter says the specific violations were: * failing to test samples of each component for identity and
FDA Policy/General
Florida has filed a second suit against FDA charging the agency is violating the Freedom of Information Act (FOIA) by withholding records requested by the state relative to its application to permit the importation of Canadian drugs. The 4/21 suit says FDA violated the FOIA by not properly responding
Drugs
FDA says its April review of Web sites maintained by Medolife Rx in Burbank, CA, determined that it markets several unapproved new drugs. A 4/19 Warning Letter says the products are concerning from a public health perspective because they claim to cure, mitigate, treat, or prevent serious and/or