FDA panel advises against Rx-to-OTC switch of Singulair
WASHINGTON — The Food and Drug Administration’s Nonprescription Drugs Advisory Committee on Friday voted 11-4 opposed to switching Merck’s allergy remedy Singulair from Rx-to-OTC, according to an Associated Press report.
According to the report, NDAC panelists questioned the safety of Singulair as an OTC remedy, especially considering patients could use it as an off-label remedy for the more serious condition asthma.
The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older.
As a prescription remedy, Singulair is also indicated to prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older, as well as to prevent exercise-induced asthma in people 6 years of age and older.
CVS/pharmacy applies for new URAC accreditation for community pharmacies
Washington — URAC, a national accreditation company, has launched a new accreditation program, Community Pharmacy, and CVS/pharmacy has stepped forward to be the first applicant organization to seek community pharmacy accreditation from URAC.
CVS/pharmacy is the retail division of CVS Caremark, which is already accredited for four out of the now six URAC’s pharmacy accreditation programs: PBM, drug therapy management, specialty pharmacy and mail service pharmacy.
To earn the accreditation, providers undergo an independent rigorous evaluation process, ensuring the achievement of accountability and quality under industry-vetted standards.
"We are pleased to be the first retail pharmacy seeking URAC’s new Community Pharmacy accreditation," stated Josh Flum, SVP of retail pharmacy at CVS Caremark. "Independently validating the quality of CVS/pharmacy’s patient services through the same accreditation process that CVS Caremark’s other pharmacy businesses have undergone demonstrates our commitment to helping our customers on their path to better health."
URAC’s Community Pharmacy Accreditation Program was developed in response to the market need to differentiate community pharmacies that engage in patient counseling and education, MTM and quality initiatives that improve care and reduce overall health care costs.
AstraZeneca announces FDA approval of Epanova (omega-3-carboxylic acids)
WILMINGTON, Del. — AstraZeneca on Tuesday announced the Food and Drug Administration approved Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).
"The FDA approval of Epanova is good news for the significant and growing population with severe hypertriglyceridemia as it offers physicians and their patients an important new treatment option that has been proven to be effective in clinical trials," stated Briggs Morrison, EVP global medicines development and chief medical officer, AstraZeneca. "This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of medicines. We are committed to further assessing the clinical profile of Epanova and identifying other patient groups it may benefit."
Epanova is the first FDA approved prescription omega-3 in free fatty acid form, AstraZeneca reported. The dosage of Epanova is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day. It can be taken with or without food.
"Patients with severe hypertriglyceridemia often have other medical conditions, such as diabetes and high blood pressure, that require them to take multiple medications," added Michael Davidson, EVP of Omthera Pharmaceuticals, an AstraZeneca company. "Although physicians will treat each patient individually, Epanova offers physicians a two-capsule dosing option, once a day with or without food. This provides physicians with a simple, patient-friendly option to effectively manage this serious condition without dramatically increasing a patient’s pill burden when prescribing the two gram dose."