CFC inhalers to be phased out by end of year, FDA says
SILVER SPRING, Md. — The Food and Drug Administration plans to complete its phase out of inhalers that contain ozone-depleting chlorofluorocarbons by the end of the year, the agency said Wednesday.
The FDA said it planned to complete the phase-out of all CFC inhalers by Dec. 31 in order to comply with international treaties. CFCs are propellants used to help patients inhale medicines, but they also deplete the ozone layer, and the United States was a signatory to the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer, along with most other countries. CFCs have since been removed from hairsprays, deodorants and air conditioning.
Most of the products containing CFCs have already been phased out, and currently, only two remain on the market: Boehringer Ingelheim’s Combivent (ipratropium bromide; albuterol sulfate) and Medicis’ Maxair (pirbuterol). The albuterol CFC inhaler, the most commonly used one, was phased out in 2008 and replaced with inhalers that use propellants called hydrofluoroalkanes, or HFAs. BI has another inhaler with the sale active ingredient, Combivent Respimat (ipratropium bromide; albuterol) that uses a mechanical propellant system.
Inhalers are most often used by people with asthma or chronic obstructive pulmonary disease — a term that encompasses chronic bronchitis and emphysema — which respectively affect 25 million and 15 million people in the United States.
"CFCs were used as propellants to move the drug out of inhalers so that patients can inhale the medicine," FDA director of the Division of Pulmonary, Allergy and Rheumatology Products Badrul Chowdhury said. "For more than two decades, the FDA and Environmental Protection Agency have collaborated to phase-out CFCs in inhalers, a process that included input from the public, advisory committees, manufacturers and stakeholders."
Air Force master sergeant Jessica Hughes named PTCB Certified Pharmacy Technician of the Year
WASHINGTON — A U.S. Air Force master sergeant has been named the Pharmacy Technician Certification Board’s Certified Pharmacy Technician of the Year, the PTCB said.
The PTCB announced that master sergeant Jessica Hughes, the non-commissioned officer in charge of pharmacy support at Joint Base McGuire-Dix-Lakehurst, in New Jersey, was selected as the PTCB CPhT of the Year. The finalists also included Rico Powell and Linda Henson.
While deployed in Afghanistan, Hughes prepared 1,300 IV medications, 70% of the total workload, and provided drug therapy support to more than 900 patients, often finding herself leaned on as a pharmacist as well as a technician because she worked overnight shifts when no pharmacist was available.
"The experience opened my eyes to much more than what I normally see in a clinic setting," Hughes said. "I was called to traumas and had to make IVs and TPNs, and I was asked about things that were new to me, but I was depended upon to find answers."
Currently, at McGuire-Dix-Lakehurst, Hughes oversees the vault, logistics and clinic inspections, playing an active role in frontline pharmacy operations, researching medication shortages and serving as a tobacco cessation instructor, achieving a 70% quit rate.
Depomed sells royalty, milestone interests in Type 2 diabetes drugs for $240.5 million
NEWARK, Calif. — Drug maker Depomed has sold its interests in royalty and milestone payments for several Type 2 diabetes drugs to PDL BioPharma, Depomed said.
The drug maker announced that it had sold its interest in the Type 2 diabetes therapeutic area to PDL for $240.5 million, which it plans to use to acquire rights to products it said would drive long-term growth and build on its expertise in pain and neurology.
The interests include payments accruing from and after Oct. 1 from Santarus, for Glumetza (metformin hydrochloride extended-release tablets) in the United States; from Merck for Janumet XR (sitagliptin and metformin hydrochloride extended-release); from Johnson & Johnson for potential future milestones and sales of Invokana (canagliflozin) and extended-release metformin; from Boehringer Ingelheim for potential future milestones and sales of experimental drugs; and from LG and Valeant for sales of extended-release metformin in Korea and Canada, respectively.
"Through this sale of our Type 2 diabetes milestone and royalty payments, we have generated a significant infusion of cash equal to approximately 55% of our market capitalization without issuing any equity or incurring any debt," Depomed president and CEO Jim Schoeneck said. "We intend to focus our cash balance of over $300 million to fund future product acquisitions capable of driving growth into the next decade."
Schoeneck said he expected such current Depomed products as the restless legs syndrome drug Gralise (gabapentin), the pain drug Lazanda (fentanyl nasal spray) and the actinic keratosis drug Zipsor (diclofenac potassium) to drive sales growth, and the company has retained its royalty and milestone interests in other collaborations, including agreements with Mallinckrodt, Ironwood and Johnson & Johnson.