PHARMACY

FDA approves new pancreatic cancer treatment

BY DSN STAFF

SILVER SPRING, Md. — The Food and Drug Administrtion on Thursday announced that it had approved Merrimack Pharmaceuticals’ Onivyde (irinotecan liposome) injection. The drug is a treatment for metastatic pancreatic cancer in combination with fluoracil and leucovorin. 
 
“Many FDA staff who review drug applications are clinicians as well, so it’s especially rewarding when we are able to expedite access to new treatments for patients with unmet needs,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival.”
 
Onivyde includes a boxed warning about potential risks of sever neutropenia and diarrhea among patients being treated with it. 
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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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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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