Drugs

Warning Letter to Firm Over Weight-loss/Diabetes Drugs

FDA has issued a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the company’s production of injectable weight-loss and diabetes drugs, including semaglutide- and tirzepatide-based products. Compounding the violations, FDA says the company refused to grant investigators access to certain areas of the manufacturing facility during the inspection. Under federal law, such actions can render products “adulterated,” regardless of their actual composition.

In the 4/14 letter, FDA says the company’s “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” are unapproved new drugs that were being distributed without required FDA authorization. The agency also found the products to be misbranded because the firm failed to properly register its operations and list its drugs with the FDA.

The enforcement action follows a February inspection of the company’s Northvale, NJ facility, during which investigators identified what the agency described as fundamental breakdowns in current good manufacturing practice (CGMP). Among the most serious concerns: the company lacked adequate procedures to ensure sterility for injectable products, raising the risk of contamination that could lead to severe infections or other life-threatening complications, according to the letter.

FDA inspectors report that the firm did not conduct key validation steps required for sterile drug production, such as aseptic process simulations or environmental monitoring. The agency contends that the company manufactured purportedly sterile products under conditions that did not meet required cleanroom standards.

The Warning Letter also highlights failures by the company’s quality unit, including a lack of proper testing for product identity, strength, and purity, as well as insufficient stability data to support expiration dates.

Following discussions with regulators, New Life Pharma voluntarily recalled batches of its semaglutide and tirzepatide products in late February due to concerns about sterility. The company also indicated it had paused manufacturing, though FDA expressed concern that it may attempt to resume production without adequately addressing deficiencies.

In unusually strong language, the agency urged the company not to restart drug manufacturing at the facility, citing both the lack of approved applications for its products and systemic failures in sterile production controls.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome