Regulatory and Washington

SILVER SPRING, Md. — The Nonprescription Drugs Advisory Committee on Thursday announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 microgram (mcg)/actuation, as a temporary reliever of mild symptoms of intermittent asthma for consumers 12 years of age and older. 

WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.

DUBLIN — The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

Actavis announced the approval of telmisartan immediate-release tablets in the 20-mg, 40-mg and 80-mg strengths, which it intends to release immediately.

WASHINGTON — A pharmacy professor and compounding pharmacy owner are candidates for president-elect of the American Pharmacists Association for 2015-2016, the group said.

The APhA said the candidates for the position are Virginia Commonwealth University School of Pharmacy professor and community pharmacy residency program director Jean-Venable Goode and Newport Beach, Calif.-based Westcliff Compounding Pharmacy owner Michael Pavlovich. Members will have the opportunity to meet the candidates at the APhA Annual Meeting and Exposition in Orlando, Fla., in March.

ALEXANDRIA, Va. —Vulnerable patients, including seniors and cancer patients, suffer from lack of access to needed painkillers as efforts to combat diversion and misuse of controlled substances often result in drugs not getting into the hands of those who need them, according to a new pharmacist survey by the National Community Pharmacists Association. 

Rather than take vacation for Christmas and New Year’s, the editors of DSN worked to compile a list of the top 10 trends that will shake up the business in 2014.

OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn's disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.

PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA's approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.