Aurobindo gains FDA approval for alprazolam tablets
DAYTON, N.J. — Aurobindo Pharma Limited on Tuesday received approval from the Food and Drug Administration for its alprazolam tablets, a generic version of Xanax. The FDA approved Aurobindo’s alprazolam tablets in 0.25- 0.5-, 1- and 2-mg dosage strengths.
Alprazolam is used to treat anxiety disorders, panic disorders and anxiety caused by depression. As a benzodiazepine, it slows down the movement of chemicals in the brain that may become unbalanced, resulting in a reduction in nervous tension.
The product has an estimated market size of $102.7MM for the 12 months ending in June 2015, according to IMS Health data.
Michael Burns honored with Wurster leadership award
LAS VEGAS — “Mission over margin.” That was the advice Michael Burns, owner of AuBurn Pharmacies and 2015 recipient of the Ken Wurster Community Leadership Award at the Cardinal Health Retail Business Conference, gave to his fellow pharmacists as he was being honored. “At the end of the day, all any of us want to do is make a difference,” he said. “That’s just like the majority of you out there today. You’re out there making a difference.”
“Our 2015 winner is a perfect example of what the Ken Wurster Community Leadership Award means,” said Chris Lanctot, vice president of Territory Sales at Cardinal Health, who presented the award. “[Burns] not only provides financial contributions to various charities, … [he] also creates foundations and scholarships at a local community hospital.”
“For more than 20 years, Michael Burns has worked diligently to increase the presence of community pharmacy in all markets, including underserved areas,” stated Steve Lawrence, senior vice president of Independent Sales for Cardinal Health. “He’s also helped struggling pharmacies remain viable businesses that contribute to their local economies by offering affordable, quality health care.”
Burns’ involvement in the community ranges from collaborating with local elementary schools to providing the AuBurn Healthy Kids Free Vitamin Program, to donating his time to lead grassroots organizations through successful bond issues to build new hospitals and schools in the areas they serve. Additionally, Burns and his company support area schools of pharmacy every year by providing mentorship, instruction and education as preceptors to dozens of pharmacy students.
Burns owns 18 retail pharmacies in 13 communities; he invested in several rural Kansas pharmacies to help provide a higher level of service and commitment. In addition to improving these pharmacies to be thriving businesses, Burns has donated more than $315,000 to various community charities, organizations, projects and causes.
To recognize Burns’ extraordinary commitment to community service, Cardinal Health donated $10,000 to the University of Kansas School of Pharmacy in his honor.
The annual Ken Wurster Community Leadership Award was created in honor of a Tampa, Fla., independent pharmacist who passed away in 2008. Wurster was highly regarded for his commitment to serving his customers.
Mylan introduces generic Nexium delayed-release capsules
HERTFORDSHIRE, England and PITTSBURGH — Mylan on Wednesday announced the U.S. launch of its generic version of Nexium (esomeprazole magnesium delayed-release capsules) in 20- and 40-mg dosage strengths.
Mylan received approval from the Food and Drug Administration for its Abbreviated New Drug Application for this product, which is used for the treatment of gastroesophageal reflux disease in adults and children ages 1 and older, the company said.
"Mylan's launch of esomeprazole magnesium delayed-release capsules USP represents our continued commitment to expand access to high quality medicine, and we're pleased to provide patients with another affordable treatment option,” Mylan CEO Heather Bresch said.
Sales of the drgu racked up to $5.2 billion for the 12 months ending June 30, according to IMS Health. Mylan now has 268 ANDAs pending FDA approval, representing $101.3 billion in annual brand sales.