FDA to begin removing inhalers containing CFC propellants from market
SILVER SPRING, Md. The Food and Drug Administration will start phasing out asthma and chronic obstructive pulmonary disease inhalers that contain ozone-depleting chlorofluorocarbons in less than two months, the agency announced Tuesday.
The agency announced in 2008 that it would require CFC as a propellant in inhalers to be replaced by hydrofluoroalkane. On June 14, King Pharmaceuticals’ Tilade (nedocromil) and Boehringer Ingelheim’s Alupent (metaproterenol) inhalers will be removed from the market, followed by Abbott Labs’ Azmacort (triamcinolone) and King’s Intal (cromolyn) in December. Forest Labs’ Aerobid (flunisolide), BI’s Combivent (albuterol and ipratropium) and Graceway’s Maxair Autohaler (pirbuterol) will disappear in 2011 and 2013.
“During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD,” FDA Division of Pulmonary, Allergy and Rheumatology Products director Badrul Chowdhury said. “We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them.”
The government began banning CFCs in consumer products in the 1970s and eliminated most CFC production in the United States in 1996. The FDA initially proposed phasing out CFC-based inhalers in 2007.
FDA tentatively approves Sun’s Namenda generic
MUMBAI, India The Food and Drug Administration has given tentative approval to a generic Alzheimer’s disease drug made by Sun Pharmaceutical Industries, Sun announced Saturday.
The FDA gave the tentative approval to Sun’s memantine tablets in the 5-mg and 10-mg strengths. The drug is a generic version of Forest Labs’ Namenda, which has annual U.S. sales of around $1.2 billion, according to Sun.
A tentative approval means that a generic drug meets the FDA’s conditions for approval, but the agency cannot grant final approval until the branded drug’s patents expire. Forest’s patent for Namenda expires in April 2015, according to FDA data.
Meijer offering free metformin to customers
GRAND RAPIDS, Mich. Meijer announced plans Monday to begin offering metformin immediate release, one of the most commonly prescribed treatments for Type 2 diabetes, at no cost to those with a prescription.
Meijer’s program — which will include doses prescribed in 500-mg, 850-mg and 1,000-mg tablets — joins other Meijer healthy-living initiatives designed to provide no-cost medicine to shoppers, including such initiatives as free children’s antibiotics and prenatal vitamins for women with a prescription. To date, Meijer has filled more than 5 million free antibiotic prescriptions, and more than 500,000 prescriptions for free prenatal vitamins. Combined, Meijer has provided a total cost savings to consumers of more than $90 million.
Meijer is one of several store chains that recently has announced free metformin offerings for customers. Last month, Publix launched a multifaceted program designed to assist customers and associates living with diabetes.
“Meijer is pleased to add metformin immediate release to our free medication program,” said Effie Steele, clinical services coordinator for the Grand Rapids, Mich.-based retailer. “As our population ages, Type 2 diabetes cases continue to grow. Adding metformin immediate release to Meijer’s free medication program, while providing other ways to manage diabetes through the various healthy living solutions offered in our stores, reinforces our commitment to promote healthy lifestyles for all of our customers.”