Popular heartburn medication returns to market with new name - Zantac 360°™ - and new active ingredient
In April 2021, Sanofi Consumer Healthcare released a new, over-the counter (OTC) medication called Zantac 360°. The medication labeling denotes a “new formula” with the active ingredient of famotidine, a different histamine-2 (H2) blocker. While labeled as a new formula, famotidine is not a new medication. Famotidine, also known under the trade name Pepcid® and Pepcid® AC, has been available OTC since 1995 and is currently available in both brand-name and generic formulations.
You may recall that Zantac and its generic ranitidine counterparts were pulled from pharmacy shelves beginning in 2019 due to the discovery of a nitrosamine impurity called
N-nitrosodimethylamine (NDMA), a probable human carcinogen. In April 2020, the U.S. Food and Drug Administration (FDA) requested the immediate removal of all prescription and OTC ranitidine products (as published on our April 2020 blog). Prior to this, ranitidine was a commonly used H2 blocker indicated to treat gastroesophageal reflux disease (GERD), heartburn and peptic ulcer disease.
Place in therapy
Treatment guidelines indicate that H2 blockers, such as famotidine, may be recommended as options for patients with dyspepsia or heartburn secondary to use with nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen.
Impact on workers’ compensation and auto no-fault
In our book of business, famotidine has been commonly prescribed for many years. As a reminder, an OTC formulation of famotidine can be dispensed at the pharmacy if the prescription formulation is allowed on the formulary. To encourage use of the OTC formulation, prescribers should mark “OTC” on the front of the prescription.
Impact on Optum Settlement Solutions
Zantac 360° is available in two strengths, containing famotidine 10 mg and famotidine 20 mg. As a brand-only, OTC-only product, Zantac 360° is not included in Workers’ Compensation Medicare Set-Aside (WCMSA) allocations by the Centers for Medicare and Medicaid Services (CMS). However, generic prescription famotidine, available in 20 mg and 40 mg strengths, is the most cost-effective H2 blocker currently available for allocation in WCMSAs.