FDA Approves Two Generics from Amneal Pharmaceuticals for Alzheimer and Oncology, with Tentative Approval for Gastrointestinal Disease

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The FDA has approved Amneal Pharmaceuticals’ memantine/donepezil extended-release capsules for Alzheimer disease (AD), a generic of Abbvie’s Namzaric, as well as Everolimus extended-release capsules, which references Novartis’ Afinitor Disperz. Additionally, Amneal received tentative approval for rifaximin tablets for irritable bowel syndrome (IBS), a reference of Bausch Health’s Xifaxan, pending litigation resolution.¹

“Amneal’s competitive advantage in the Affordable Medicines business remains our core capabilities to drive innovation at scale across complex categories to expand the breadth and depth of our portfolio,” said Andy Boyer, EVP, chief commercial officer, Affordable Medicines, in a press release. “With our 180-day exclusivity on memantine/donepezil, increasing supply for everolimus, and the tentative approval of rifaximin, we are continuing to expand our differentiated portfolio and providing new key therapies for our customers, providers and patients.”

Namzaric was first approved in December 2014 for the treatment of AD. Both drugs included in the treatment, memantine as Namenda XR, and donepezil as Aricept, are also available as single ingredient products. Currently, the treatment is available in 28 mg/10 mg (memantine extended release/donepezil), and 14 mg/10mg for patients with severe renal impairment.² Common adverse events (AEs) with memantine hydrochloride include headache, diarrhea, and dizziness, while common AEs for donepezil include diarrhea, anorexia, vomiting, nausea, and bruising.¹

Afinitor Disperz was first approved in March 2009 in patients with advanced kidney cancer after failure with either sunitinib or sorafenib. Additional indications include advanced HR-positive, HER2-negative breast cancer; progressive neuroendocrine tumors of pancreatic origin; progressive neuroendocrine gastrointestinal or lung tumors; advanced renal cell carcinoma; and subependymal giant cell astrocytoma and renal angiomyolipomas associated with tuberous sclerosis.³

Xifaxan was first approved in May 2004 for traveler's diarrhea caused by noninvasive strains of Escherichia coli. It has since been approved for patients with liver disease and to reduce the risk of IBS with diarrhea.⁴

According to the World Health Organization, AD is the most common form of dementia, possibly contributing to 60% to 70% of all diagnosed cases.⁵ According to the Alzheimer’s Association, around 6.9 million people in the United States over 65 years of age are currently living with AD. Additionally, around two-thirds of people with AD are women. It is also estimated that by 2050, the number of people in the United States with AD is expected to grow to 12.7 million.⁶

IBS is estimated to affect anywhere from 5% to 10% of the global population. In most cases, most people with IBS are under 50 years of age, but older people can get it as well. Additional statistics suggest that anywhere from 20% to 20% of all visits to gastroenterologists are due to IBS symptoms. Four out of five people with IBS report that pain is the most significant factor contributing to their symptoms. A survey by the International Foundation for Gastrointestinal Disorders found that respondents reported a 31.4% rate of mild IBS, 48.3% of moderate IBS, and a 20.3% rate of severe IBS.

In the United States, IBS affects between 25 and 45 million people, of whom, two out of three are female. Considered to be a major women’s health issue, IBS can result in an increased risk of unnecessary surgery for extra-abdominal and abdominal surgery. For women, this includes hysterectomy or ovarian surgery, with numbers ranging from 47% to 55%. Symptoms are also found in 6% to 14% of adolescents.⁷

References

1. Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin. Amneal. January 23, 2025. Accessed January 23, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U.S.-FDA-Approval-for-MemantineDonepezil-Extended-Release-Capsules-and-Everolimus-Tablets-for-Oral-Suspension-and-Tentative-U.S.-FDA-Approval-for-Rifaximin/default.aspx

2. Namzaric FDA Approval History. Drugs.com. Accessed January 23, 2025. https://www.drugs.com/history/namzaric.html

3. Afinitor FDA Approval History. Drugs.com. Accessed January 23, 2025. https://www.drugs.com/history/afinitor.html

4. Xifaxan FDA Approval History. Drugs.com. Accessed January 23, 2025. https://www.drugs.com/history/xifaxan.html

5. Dementia. WHO. Accessed January 23, 2025. https://www.who.int/news-room/fact-sheets/detail/dementia

6. Alzheimer's Disease Facts and Figures. Alzheimer’s Association. Accessed January 23, 2025. https://www.alz.org/alzheimers-dementia/facts-figures

7. IBS Facts and Statistics. IIFGD. Accessed January 23, 2025. https://aboutibs.org/what-is-ibs/facts-about-ibs/