Mylan receives FDA approval for generic Depakote Sprinkle capsules
PITTSBURGH — The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.
Mylan said Monday that the FDA had approved its divalproex sodium capsules in the 125-mg strength. The drug is a generic version of Abbott’s Depakote Sprinkle capsules and is used to treat certain types of epileptic seizures.
Divalproex sodium capsules had sales of about $89 million during the 12-month period ended in March, according to IMS Health.
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FDA approves Incivek as hepatitis C treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.
The FDA approved Incivek (telaprevir) to treat adults with chronic hepatitis C infection, particularly those who either have not received interferon-based drug therapy or who have not responded to prior therapies. The drug is approved for use with therapies that include ribavirin and peginterferon alfa.
“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” FDA Office of Antimicrobial Products director Edward Cox said. “The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection.”
The announcement comes a little more than a week after the FDA approved Merck’s hepatitis C drug Victrelis (boceprevir).
if and when approved what type is it for as i have 3a
Allowing pharmacists to immunize patients cuts costs for patients, healthcare delivery
WHAT IT MEANS AND WHY IT’S IMPORTANT — The Louisiana State Senate has given the green light to legislation that would expand pharmacy’s ability to administer immunizations, and now the House of Representatives is slated to vote on the legislation in the coming days. The passage of SB 60 is important because expanding the pharmacist’s ability to administer vaccinations is a relatively low-cost way to expand access and ultimately improve outcomes.
(THE NEWS: Louisiana seeks to expand pharmacy’s ability to immunize patients. For the full story, click here.)
In terms of the reach, look at Walgreens as an example, which has a network of certified immunizers and other healthcare professionals of more than 26,000. One of Walgreens’ most successful initiatives in fiscal year 2010 was its expanded flu shot program. Its pharmacists and Take Care nurse practitioners and physician assistants provided 5.4 million seasonal flu shots — more than four times the number the previous year — and another 2 million H1N1 shots.
What kind of effect can that have? Well, a study released in April by the Ohio Department of Health estimated that Ohio’s H1N1 vaccination efforts prevented 64 deaths, 1,400 hospitalizations and 310,402 cases of influenza during the 2009 H1N1 pandemic. The study also estimated that Ohio’s vaccination efforts saved the state $8.4 million in H1N1-related hospitalization costs.
To protect Ohio residents from the pandemic, ODH had ordered and shipped 4.1 million doses of vaccine to more than 3,000 providers, including obstetricians, primary care physicians, local health departments and pharmacies from across the state. In addition, ODH released more than $50 million in federal emergency public health preparedness funds — more than 90% of the funds received by Ohio — to support numerous vaccination clinics and prevention efforts at the local level.
Clearly, enabling pharmacists to administer immunizations, and thereby improving patient access to care, results in reduced costs for both patients and the overall healthcare delivery system.
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