Mfg News: Pfizer, Novo Nordisk, Checkpoint Therapeutics & FDA
A roundup of manufacturing news from Pfizer, Novo Nordisk, Checkpoint Therapeutics and the FDA. Highlights below.
* Pfizer’s Hospira Issues Voluntary Recall of Three Sterile Products Due To Glass Particulates
* FDA Investigates Counterfeit Ozempic in US Supply Chain
* FDA Issues CRL to Checkpoint Therapeutics for Mfg Issues at CDMO
* FDA Issues New Guidance on Benzene Impurities in Certain Drug Products
Pfizer’s Hospira Issues Voluntary Recall of Three Sterile Products Due To Glass Particulates
Hospira, a Pfizer company, is voluntarily recalling select lots of three sterile drugs to the user level due to the potential presence of glass particulate matter, identified during product inspection. The products are: 4.2% sodium bicarbonate injection, USP Abboject Glass Syringe, 5 mEq/10 mL; 8.4% sodium bicarbonate injection, USP Lifeshield Abboject Glass Syringe, 50 mEq/50 mL; and atropine sulfate injection, USP Lifeshield Abboject Glass Syringe, 1 mg/10 mL.
To date (as reported on December 21, 2023), Hospira says it has not received reports of any adverse events associated with this issue for these lots. This recall is being executed with the knowledge of the US Food and Drug Administration.
Source: US Food and Drug Administration
FDA Investigates Counterfeit Ozempic in US Supply Chain
The US Food and Drug Administration reported in late December (December 2023) that it is investigating counterfeit versions of Novo Nordisk’s Ozempic (semaglutide) injection 1 milligram (mg) found in the legitimate US drug supply chain. The agency said (as reported on December 21, 2023) that is has seized thousands of units of the product and that some counterfeit products may still be available for purchase.
Additionally, analysis found the needles from the samples are counterfeit. Accordingly, the agency said that sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on analyses completed to date (as of December 21, 2023), other confirmed counterfeit components within the seized products are the pen label, accompanying healthcare professional and patient information, and the carton.
FDA says it is aware of five adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain and constipation.
FDA’s investigation is ongoing, and the agency says is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the US.
Source: US Food and Drug Administration
FDA Issues CRL to Checkpoint Therapeutics for Mfg Issues at CDMO
The US Food and Drug Administration (FDA) has issued Checkpoint Therapeutics, a Waltham, Massachusetts-based bio/pharmaceutical company, a Complete Response Letter (CRL) related to manufacturing issues in the biologic license application (BLA) of cosibelima, an anti-cancer drug, found during FDA’s inspection of the company’s third-party contract manufacturer.
Cosibelimab is currently under review by the FDA as a potential new treatment for patients with locally advanced and metastatic cutaneous squamous cell carcinoma.
The company says that the CRL cites findings that arose during a multi-sponsor inspection of Checkpoint’s CMO and did not include concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. The company said that it will address the feedback in a resubmission to enable marketing approval for the drug in 2024. .
Source: Checkpoint Therapeutics
FDA Issues New Guidance on Benzene Impurities in Certain Drug Products
The US Food and Drug Administration (FDA) has issued a new guidance to help drug manufacturers limit consumers’ and patients’ exposure to unacceptable levels of benzene in certain drug products. The guidance provides manufacturers with recommendations for testing and documentation related to reformulation of drug products that use carbomers manufactured with benzene, taking into consideration the various routes of administration and dosage forms of affected drug products.
Source: US Food and Drug Administration
