New Formulations for Popular Meds; Nicotine and Health Risks; Generic Facility Warned; Anti-Aging Emerging Therapies and Hype; More
Nicotine Pouches Ok'd by FDA
The U.S. FDA (Food and Drug Administration) authorized the marketing of 10 flavors of “ZYN” brand nicotine pouch products (each available in two nicotine strengths, 3 milligram or 6 milligram) through the premarket tobacco product application (PMTA) pathway. A PMTA is a type of application for any new "tobacco" product seeking an FDA marketing order. The ZYN nicotine pouches do not contain any tobacco.
Nicotine pouches, which are placed between a person’s gum and lip, have been sold in the U.S. for ten years without official authorization by the FDA. After a scientific evaluation, the FDA concluded that the non-tobacco containing nicotine pouch products pose lower risk of cancer and other serious health problems than cigarettes and most smokeless tobacco products, due to substantially smaller amounts of harmful ingredients. The FDA said it will closely monitor youth use and compliance with marketing restrictions. The company is prohibited from marketing the products to people under the age of 21.
FDA Press Release on ZYN Nicotine Pouches
Not everyone is supportive of the FDA’s decision. Questions remain about whether the pouches affect gums, teeth, or cardiovascular health. A spokesperson for the Campaign for Tobacco-Free Kids is concerned that these flavored products “appeal to and addict kids."
https://www.cbsnews.com/news/zyn-health-impacts-controversial-nicotine-pouch/
Proposal to Reduce Nicotine Levels in Cigarettes
Because nicotine is highly addictive, the FDA is taking comments on a proposal to reduce the amount of nicotine in cigarettes, cigars, and pipe tobacco. The proposed rule does not include e-cigarettes, nicotine pouches, non-combusted cigarettes (such as heated tobacco products that meet the definition of a cigarette), waterpipe tobacco (hookah), smokeless tobacco products, or premium cigars. Newly authorized ZYN nicotine pouches contain 3 mg or 6 mg of nicotine per pouch; Nicotine in cigarettes would be reduced from average of 17mg per gram of tobacco to a cap of .7 mg per gram of tobacco.
“This is probably one of the most significant things that the FDA has done in its history to affect or limit tobacco use," said Dr. Jamie Garfield, a Temple Health pulmonologist and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine. - PhillyVoice
Expanded Approval for Spravato Antidepressant
The FDA expanded its approval of Spravato (esketamine) nasal spray for treatment-resistant depression: it may now be used as a stand-alone treatment for major depression that has not responded to other treatments. Previously, it was approved as an add-on treatment with oral antidepressants. Spravato has a boxed warning about the risk of sedation, dissociation, and respiratory depression. It is administered by a health care professional.
https://health.wusf.usf.edu/npr-health/2025-01-21/fda-allows-standalone-use-of-nasal-spray-antidepressant-spravato-esketamine
Read about Spravato’s November 2024 safety label update:
https://news.askapatient.com/i/151792404/spravato-esketamine-nasal-spray
New Dissolvable Film formulation of Viagra (sildenafil) Available in Canada: in the Works for U.K.; Trademark Application Filed in U.S.
Viatris was formed in 2020 by the merger of generic drug company Mylan and Pfizer’s Upjohn division. Viatris owns the erectile dysfunction drug Viagra (sildenafil) name and brand. It recently applied for a trademark in the UK for a new formulation of the drug, called Viagra ODF, which dissolves on the tongue (with or without water) instead of being swallowed as a "little blue pill." Viatris will still need to gain approval by the drug regulatory agencies in order to market the drug. The active ingredient, sildenafil, has been available as a generic since 2018; Viagra was initially approved in 1998.
In September 2024, Viatris launched the Viagra ODF in Canada, announcing that it “offers a new option for those who value convenience and discretion." A new trademark application featuring a new logo for Viagra was also filed in the U.S. in September for an "orodispersible film to treat erectile dysfunction." The application is still pending.
https://www.telegraph.co.uk/news/2024/12/15/discreet-new-form-of-viagra-could-replace-little-blue-pill/
United States Trademark Application Page for Viagra Trademark
Patient Ratings for Viagra
Oral disintegrating medications have become increasingly popular in recent years. Last July, the first such birth control tablet was approved:
https://news.askapatient.com/i/147108257/dissolving-birth-control-pill
Quality Problems at Viatris Generic Manufacturing Facility in India
Viatris received a warning letter and “Import Alert” from the FDA for eleven drugs because of quality control problems, including inadequate record keeping, at its Indore, India, facility. The People’s Pharmacy's Joe Graedon investigated related documents publicly available at the FDA, but could not find a list of the names of the eleven affected generic drugs.
https://www.peoplespharmacy.com/articles/another-disappointing-drug-import-alert-from-india
Opdivo New Subcutaneous Formulation
Bristol Myers Squibb received FDA approval for a subcutaneous version of its cancer drug Opdivo (nivolumab and hyaluronidase-nvhy injection). Called Opdivo Qvantig, the new formulation is approved to treat solid tumors in adults, including indications for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Opdivo (nivolumab injection) was originally approved in 2014.
Setting the Record Straight on Anti-Aging Interventions
Eric Topol interview with Venki Ramakrishnan: The New Science of Aging
A leader in molecular biology sets the record straight on human anti-aging interventions, which aim to extend human lifespan by delaying or even turning back the aging process. Professor Venki Ramakrishnan from MRC Laboratory of Molecular Biology research institute in Cambridge, UK, 2009 Nobel laureate in Chemistry and author of Why We Die, talks about the biology of aging along with his interpretations and views of emerging methods to combat aging. In this fascinating 40 minute podcast, physician-scientist Eric Topol interviews Ramakrishnan about blood based therapies (sometimes called "young blood"), caloric restrictions ("starvation diets"), "Yamanaka Factors" gene therapy to reduce signs of aging, and anti-aging drugs called senolytics. The hype is put into perspective.
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