FDA OKs infant-specific dose of Creon
ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.
Abbott announced the approval of an infant-specific dose of Creon (pancrelipase) delayed-released capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.
Most infants with the disease require small doses of pancreatic enzyme replacement therapy with every feeding, but parents or caregivers previously had to open a capsule and measure out a portion of the contents. The new capsule will allow them to provide a more precise dose.
“We know that the need for consistent, precise dosing of pancreatic enzyme replacement therapy is critical for infants and children living with cystic fibrosis,” Abbott VP global pharmaceutical development Eugene Sun said. “This approval means that Creon will now be available in four dosing options, including both the lowest and highest dosage strengths available to patients in the United States, providing improved dosing titration options and flexibility into adulthood.”
Lilly for Better Health provides patients with ways to improve well-being
INDIANAPOLIS — Drug maker Eli Lilly has created a multichannel platform to inform and educate patients about healthy eating, physical activity and stress management.
The program, Lilly for Better Health, is designed to help users live healthier, more active lives, and Lilly said it was designed to reach patients where they like to receive health information. The program includes a website, LillyForBetterHealth.com.
“Lilly’s work to improve patients’ health and well-being goes beyond medicine,” Lilly VP U.S. medical division Jack Harris said. “Managing your health and achieving a balanced lifestyle often means making changes to your daily life, and small steps can make a big difference.”
Cypress gets OK for cough-cold medications Zutripro, Rezira
MADISON, Miss. — The Food and Drug Administration has approved two cough-cold medications made by Cypress Pharmaceutical, the company said Monday.
Cypress announced the approval of Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride) and Rezira (hydrocodone bitartrate and pseudoephedrine). Both drugs are oral solutions and, because they contain the opioid hydrocodone, are classified as schedule III controlled substances by the Drug Enforcement Administration. Cypress subsidiary Hawthorn Pharmaceuticals will market the drugs.
“Currently, there are very few prescription products for patients suffering from cough and the symptoms associated with the common cold,” Hawthorn EVP sales Chris Smith said.
Cypress said the drugs are the only FDA-approved hydrocodone cough-cold combinations containing a nasal decongestant and that the approval marked the first time the FDA approved new hydrocodone cough medications since 1990.