FDA approves new allergy drug for children
MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said Wednesday.
Tris announced the approval of Karbinal ER (carbinoxamine maleate) extended-release oral suspension in the 4 mg-per-five milliliter strength. The company said the drug was the first sustained-release histamine receptor blocking agent for seasonal and perennial allergic rhinitis in children 2 and older.
"Karbinal ER is dosed only once every 12 hours, making it an attractive treatment option for the millions of allergy sufferers who don’t respond to second-generation antihistamines and aren’t satisfied with the cumbersome dosing schedules associated with the first-generation antihistamines," Tris Pharma president and CEO Ketan Mehta said. "The approval of Karbinal ER marks our fourth liquid extended-release NDA approval based on our proprietary OralXR+ technology."
FDA approves Mylan genital herpes ointment
PITTSBURGH — The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said Wednesday.
Mylan announced the approval of acyclovir ointment in the 5% strength. The drug is a generic version of Valeant International’s Zovirax, used to manage initial genital herpes and in limited, non-life-threatening mucocutaneous herpes simplex virus infections in patients with compromised immune systems.
Various versions of the drug had sales of about $230 million in 2012, according to IMS Health. Mylan said it would start shipping the drug immediately.
NCPA responds to CMS call letter
ALEXANDRIA, Va. — The recent call letter released by the Centers for Medicare and Medicaid Services addresses issues that can have an adverse effect on the program’s cost and quality of care, a trade group representing independent retail pharmacies said Wednesday.
Commenting on the CMS’ announcement, the National Community Pharmacists Association said it had prepared a detailed list for its members.
"NCPA staff and members will continue to work constructively with Medicare, Congress and others to maximize the health outcomes and cost efficiency of the Medicare prescription drug program," NCPA president and CEO B. Douglas Hoey said. "NCPA thanks its community pharmacist members and their patients who have weighed in with Medicare officials regarding these issues in the weeks and months leading up to the final 2014 call letter."
In particular, the NCPA said "egregious" pharmacy audits were collecting substantial amounts of money from pharmacies over "trivial clerical issues" instead of targeting a few bad actors; the group expressed agreement with Medicare’s statement that Part D plans should only recoup the full amount of a prescription claim under certain circumstances, such as a fraudulent or duplicate claim. Secondly, the group expressed support for Medicare’s statement that the best way to encourage price competition and lower costs is to allow any willing pharmacy to participate in preferred networks because preferred-pharmacy drug plans were creating concerns about access for elderly people, particularly those in rural areas, by excluding many independent pharmacies and regional chains. Thirdly, the NCPA said auto-shipping by mail-order pharmacies generated wasteful spending and inconvenience for patients, noting Medicare’s statement that pharmacies offering drug-disposal programs have documented patients turning in large quantities of unneeded medication received from auto-ship refill programs and that stronger opt-in protections may deter waste. In addition, the NCPA said, recent research has indicated that community pharmacies provide 90-day medication supplies at lower costs than mail-order pharmacies and substitute cheaper generics more often.