PHARMACY

Camber launches generic Singulair chewables

BY David Salazar

PISCATAWAY, N.J. — Camber Pharmaceuticals announced Thursday that it had launched its generic version of Singulair (montelukast sodium) chewable tablets. The drug is indicated for chronic asthma treatment in adults and children ages 1 year and older.  
 
Camber will sell 4- and 5-mg tablets in bottles of 30 and 90, and will sell 10-mg tablets in 30-, 90- and 1000-count bottles. 
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PHARMACY

FDA approves Impax’s generic Intuniv

BY David Salazar

HAYWARD Calif. — Impax Laboratories announced Thursday that the Food and Drug Administration had approved its generic version of Shire’s Intuniv (guanfacine) extended-release tablets.

The drug is indicated to treat attention deficit/hyperactivity disorder in children and adolescents ages 6 to 17. The drug will be available from Impax in 1-, 2-, 3- and 4-mg dosage strengths.

For the 12 months ended August 2015, brand and generic sales of guanfacine extended-release tablets were about $689 million. 

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FDA approves new hyperkalemia drug

BY David Salazar

SILVER SPRING, Md. — The Food and Drug Administration Thursday announced that it had approved Relypsa’s Veltassa (patiromer) for oral suspension. The drug is indicated to treat hyperkalemia, which is the presence of too much potassium in the blood and typically occurs among patients with kidney disease, or heart failure.

“We are very excited to bring people with hyperkalemia the first new medicine in more than 50 years,” Relypsa president and CEO John A. Orwin. “The FDA approval of Veltassa represents approximately a decade of research by dedicated scientists and doctors, and underscores Relypsa's commitment to developing polymer-based treatments for people with conditions that are often overlooked and undertreated.” 

Veltassa, which is powdered, is mixed with water and taken by mouth. The drug works by binding potassium in the gastrointestinal tract, and the potassium is then excreted through the body through the normal excretion process. Veltassa was approved with a boxed warning, which recommends taking Veltassa and another oral medication six hours apart because it can bind to orally taken drugs and reduce their absorption, the FDA said. 

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