FDA approves 2 Perrigo topical generics
The Food and Drug Administration has approved two topical generics from Perrigo, with one of them launching immediately. The agency approved the company’s generic of Estrace Cream (estradiol vaginal cream, 0.01%) and Epiduo Gel (adapalene and benzoyl peroxide gel, 0.1/2.5%).
The Epiduo Gel generic — a topical treatment for acne vulgaris in patients 9-years-old and older — will launch immediately, the company said. The product had U.S. sales of roughly $164 million for the past 12 months, according to IQVIA data.
The Estrace Cream generic is indicated to treat severe symptoms of vulvar and vaginal atrophy due to menopause, and the company said that its partner Impax Labs would be marketing the generic. Perrigo said the product would launch in the second quarter of 2018. The drug had U.S. sales of roughly $457 million for the past 12 months, based on IQVIA data.
New generics company emerges from unlikely source
There will soon be a new generics manufacturer to contend with — one that comes with a built-in base of 450 hospitals. Four major health systems — Salt Lake City-based Intermountain Healthcare, alongside Ascension, SSM Health and Trinity Health — are coming together to create a nonprofit generic drug company in consultation with the Department of Veterans Affairs.
The health systems expect the effort to be an FDA-approved manufacturer that will either directly manufacture or sub-contract the manufacture of generics in an effort to create affordable medications. Intermountain Healthcare president and CEO Marc Harrison said that the effort would bring necessary competition to the generics market.
The as-yet-unnamed company’s formation will be guided by an advisory committee composed of pharmaceutical industry and regulatory veterans, including former administrator of the Centers for Medicare and Medicaid Services Don Berwick and Madhu Balachandran, formerly Amgen’s executive vice president of global operations, among others.
“This initiative has the potential to greatly expand the availability and affordability of critically needed medications for millions of Americans, especially for people living in poverty and those most vulnerable,” said Anthony Tersigni, president and CEO of St. Louis-based Ascension.
“Rather than waiting and hoping for generic drug companies to address this need, we are taking this bold step on behalf of those we are privileged to serve. I’m pleased to see our respective systems come together, along with the VA, to ensure affordability and access to these essential medications.”
The Veterans Health Administration’s executive in charge, Caroline Clancy, praised the effort, noting, “Increasing generic drug manufacturing capacity will generate a more stable generic drug supply and will reduce the negative clinical impact of chronic drug shortages, including the impact on our nation’s veterans.”
Publix starts low-priced prescription service
Publix Pharmacy has announced the launch of a new low-priced program aimed towards providing up to a 90-day supply of commonly prescribed generic medications to customers. Medications used to treat a variety of health issues are to be included in the deal with each costing no more than $7.50.
“Our founder, George Jenkins, taught us to take care of people and our communities, and making needed medications more affordable provides us this opportunity,” Maria Brous, Publix’s director of media and community relations, said. “Healthcare costs continue to rise, so sometimes people have a hard time filling their prescriptions as regularly as they should. We believe this low price will help encourage customers to follow their doctor’s orders, so they can experience better health outcomes.”
Regardless of patient insurance coverage, the price is set to remain the same, the Lakeland, Fla.-based company said. The program is set to include 29 generic medications with 85 dosage options for treatments of:
- heart health/cardiovascular;
- mental health;
- seizure disorders;
- Parkinson’s disease;
- Alzheimer’s disease;
- gastrointestinal issues;
- asthma and allergies;
- men’s health; and
- women’s health.
A full list of medication brands can be found on Publix’s pharmacy website.