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news.The US Food and Drug Administration (FDA) has granted approval for Amneal Pharmaceuticals’ three medications, memantine/donepezil extended-release capsules and everolimus tablets for oral suspension, with tentative approval for rifaximin oral tablets.
The launch of the tablets for oral suspension is set to upsurge the supply of an oncology product with limited suppliers. Credit: danilo.alvesd on Unsplash.
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Memantine/donepezil 14-10 mg and 28-10 mg capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
This product, referencing NAMZARIC of AbbVie, has been launched with 180-day exclusivity. Adverse events associated with memantine hydrochloride include diarrhoea, dizziness, and headache while those for donepezil are anorexia, vomiting, bruising, nausea, and diarrhoea.
Additionally, everolimus 2 mg, 3 mg, and 5 mg extended-release capsules, referencing AFINITOR DISPERZ of Novartis, have been approved for treating tuberous sclerosis complex (TSC)-associated subependymal giant cell astrocytoma (SEGA) in adults and paediatric individuals of one year or above age.
The launch of these tablets for oral suspension is set to upsurge the supply of an oncology product with limited suppliers.
Respiratory tract infection and stomatitis are the common adverse events for TSC-Associated SEGA-treated subjects.
The FDA’s tentative approval of rifaximin 550 mg oral tablets, indicated to treat irritable bowel syndrome with diarrhoea (IBS-D) in the adult population, is pending due to ongoing litigation, the company noted.
Affordable Medicines chief commercial officer and executive vice-president Andy Boyer said: “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.
“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.”
Headquartered in the US, Amneal has a portfolio of more than 280 generic and specialty pharmaceuticals, primarily within the country.
The company is expanding various complex product categories and therapeutic areas, which encompass injectables and biosimilars in its Affordable Medicines segment.
It distributes pharmaceuticals and other products for the US federal government, retail, and institutional markets via its AvKARE segment.
