PHARMACY

FDA approves first generic versions of Abilify

BY Ryan Chavis

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced approval for the first generic versions of Abilify (aripiprazole) tablets, an antipsychotic drug indicated for the treatment of schizophrenia and bipolar disorder.
 
The following companies been granted approval by the FDA to market generic aripiprazole: Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals. 
 
“Having access to treatments is important for patients with long-term health conditions,” said John Peters, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug.”
 
About one percent of Americans have schizophrenia, the FDA said. Symptoms first appear in adults younger than 30 years of age and include “hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn.”

Bipolar disorder — also referred to as manic-depressive illness — causes shifts in mood, energy and activity levels and can affect a person’s ability to perform daily tasks, the FDA stated. Symptoms can include periods of depression, increased activity and restlessness and impulsive behavior, among others. 

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PHARMACY

Teva launches generic Abilify tabs

BY Ryan Chavis

JERUSALEM — Teva Pharmaceutical announced the launch of aripiprazole tablets in 2-, 5-, 10-, 15, 20- and 30-mg strengths in the United States. According to the company, the drug — a generic version of Abilify tablets — is used to treat schizophrenia as well as the acute treatment of manic and mixed episodes associated with bipolar I disorder. 
 
Schizophrenia is a long-term illness that alters a person’s ability to think clearly, manage their motions and make decisions, Teva stated, adding that one percent of Americans live with the illness. People dealing with schizophrenia may experience such symptoms as hallucinations, trouble with thinking and concentration and lack of motivation.  
 
Bipolar I is characterized by manic or mixed episodes where a person experiences extreme irritability or euphoria. According to Teva, it’s the most severe form of the illness because of the extreme manic episodes associated with it. 
 
“Our commitment at Teva is to make affordable, high-quality generic medicines available to millions of patients every day. We are pleased to launch generic Aripiprazole tablets and offer a generic treatment for patients suffering from schizophrenia and bipolar I disorder,” said Siggi Olafsson, president and CEO, global generic medicines for Teva.
 
Abilify tablets are marketed by Otsuka Pharmaceutical. The drug had annual sales of $7.8 billion in the United States as of December 2014, according to IMS data. 
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Survey: More than 50% of ACS patients do not follow prescribed OAP regimen

BY Ryan Chavis

PARSIPPANY, N.J. and INDIANAPOLIS — When people with acute coronary syndrome undergo an angioplasty procedure and receive a heart stent, they’re usually prescribed an oral anti platelet therapy and aspirin to prevent a heart attack, a blood clot in the heart stent (also known as stent thrombosis) or even death. 
 
But a recent Harris Poll survey found that 52% of 275 ACS patients currently taking an OAP missed taking or changed the way they take their prescribed OAP therapy, even after being informed by their doctors of its importance. Of the respondents, those under age 65 years — 194 participants — were more likely not to follow their OAP regiment as prescribed than older respondents. 
 
To address the issues, the Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions and Mended Hearts, with help from Daiichi Sankyo and Eli Lilly and Co., are asking healthcare professionals to increase efforts to help ACS patients adhere to their prescribed OAP therapy following an angioplasty or cardiac stent procedure. 
 
"For people who have recently received a heart stent for ACS, changing, skipping or discontinuing OAP therapy increases the risk of serious heart problems or even death," said Jeffrey Cavendish MD, FSCAI, FACC, lead interventional cardiologist for Kaiser Permanente San Diego and director of the cardiac catheterization laboratory at the Scripps Prebys Cardiovascular Institute in La Jolla, California.
 
SCAI, PCNA and Mended Hearts are rolling out the “After the Stent: Follow Your Action Plan” campaign with a goal of improving patient knowledge and practices related to OAP regimens. 
 
"Patients may stop taking their OAP medication for a variety of reasons, such as mistakenly believing their heart condition is 'fixed' or not understanding why or how long they need to take the medication," said Lola Coke, PHD, ACNS-BC, RN-BC, FAHA, FPCNA, associate professor of nursing and cardiovascular clinical nurse specialist at Rush University Medical Center in Chicago, Illinois, and member of the board of directors of PCNA. "Identifying and correcting these misunderstandings is a first step health care professionals can take to ensure medication adherence. Health care professionals need to make sure that ACS patients and caregivers have the right information and support to follow their medication regimens."
 
PCNA and SCAI published a position paper demonstrating the need for increased attention to OAP medication and provides research-based solutions to address non adherence. The paper can be viewed here.
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