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Abbott receives fda approval for heat-stable norvir® tablet
FOR IMMEDIATE RELEASE
Abbott Receives U.S. FDA Approval for Heat-Stable Norvir ® (ritonavir) Tablets
ABBOTT PARK, Ill., Feb. 11, 2010 – Abbott announced today that the U.S. Food and
Drug Administration (FDA) has granted approval of a new tablet formulation of the
company's antiretroviral medication Norvir ® tablets can be
stored at room temperature and do not require refrigeration, making it more
convenient for patients. The Norvir tablets and the Norvir soft-gelatin capsules both
contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no
Dirk Van Eeden
requirement for dosage change. Norvir is used in combination with other antiretroviral
medications to treat HIV. All forms of Norvir, including the soft-gel capsule and liquid
form, remain available in the United States.
"Norvir has been a critical component of HIV treatment for many patients. The
innovation behind the development of the Norvir tablet is the direct result of years of
effort by Abbott scientists to address the needs of people living with HIV," said Scott
Brun, M.D., divisional vice president, infectious disease development, Global
Pharmaceutical Research and Development, Abbott. "Abbott has been dedicated to
finding new and more convenient ways for patients to manage their HIV through the
development of novel diagnostics testing methods and medications for more than 20
Abbott scientists evaluated several candidate formulations before developing the final
Norvir tablet formulation. The tablet was developed using Abbott's Meltrex®
technology, a proprietary melt-extrusion process, making it more heat-stable. This is
"Approximately one-third of all HIV-positive patients in treatment use Norvir in
combination with other antiretroviral medicines. The heat-stable tablet formulation
may allow these patients greater flexibility to store and carry their medication with
them," said Renslow Sherer, M.D., professor of medicine, section of infectious
diseases and global health and director, International HIV Training Center, University
of Chicago Hospitals. "For patients who may not have access to refrigeration, this
Important Information About Norvir
Do not take Norvir with certain medicines, as these can cause serious or life-
such as irregular heartbeat, breathing difficulties, or excessive
sleepiness. Do not take Norvir if you have had a serious allergic reaction to any of its
ingredients. Some patients taking Norvir may develop liver and pancreas problems,
which can cause death. Patients may develop large increases in triglycerides and
cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in
people with hemophilia, allergic reactions, and/or changes in heart rhythm. You may
develop signs and symptoms of infections that you already have after starting anti-
HIV medicines. Please see the Important Safety Information for more details.
Important Information About Kaletra
Do not take Kaletra if you are allergic to any of its ingredients, including lopinavir or
ritonavir. Do not take Kaletra with certain medicines, as they can cause serious
problems, death, or make Kaletra less effective against HIV. Some patients taking
Kaletra can develop inflammation of the pancreas and liver problems, which can
cause death. Patients may develop changes in heart rhythm, large increases in
triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, and/or
increased bleeding in people with hemophilia. Some patients may develop signs and
symptoms of serious infections they already have after starting anti-HIV medicines.
Please see the Important Safety Information for more details.
The European Commission granted approval of the Norvir tablet in January. Abbott
intends to register the new Norvir tablet as broadly worldwide as the Kaletra/Aluvia®
(lopinavir/ritonavir) tablet. The Kaletra/Aluvia tablet is approved for sale, available (in
countries where no regulatory approval is needed) or has been submitted for
registration in 170 countries around the world, making it the most widely registered
antiretroviral medicine available for patients across the globe.
HIV Access Programs in the United States
To help patients access this important new formulation of Norvir, Abbott is launching a
Norvir co-pay support program which will be available in 2010 for all formulations of
Norvir. Once a patient has paid $25 in co-pays, this program will cover up to $75
each month in patient co-pays within the first 12 months. Certain restrictions may
Abbott also offers several patient assistance programs to help patients on Kaletra and
Norvir access their medications. More information about other access programs can
calling Abbott's patient access toll-free number at 1-800-222-6885.
Abbott and HIV
For more than 20 years, Abbott has made a significant contribution to the fight against
HIV/AIDS through the development of innovative tests and medicines.
• In 1985, Abbott developed the first licensed test to detect HIV antibodies in the
blood. The company remains a leader in HIV diagnostics today
• In 1992, Abbott was the first company to receive FDA approval for an HIV
diagnostic assay. Abbott retroviral and hepatitis tests are used to screen more
than half of the world's donated blood supply
• In 1996, Norvir was approved for the treatment of HIV in the United States.
Norvir was one of the first protease inhibitors on the market and remains one
of the most commonly prescribed medicines as part of combination therapy
• In 1997, Norvir became one of the first protease inhibitors to receive FDA
• In 2000, Abbott received FDA accelerated approval for Kaletra • In 2005, the tablet form of Kaletra received FDA approval
• In 2006, Kaletra tablets received EMEA approval • In 2007, Abbott received FDA approval for a new lower-strength Kaletra tablet
• In 2007, Abbott's RealTime HIV-1 Viral Load test was approved by the FDA
for use on the m2000™ molecular diagnostics instruments
• In 2009, Abbott received approval from the FDA for its ABBOTT PRISM HIV O
Plus test, the first fully-automated blood screening test for HIV-1/HIV-2
• In 2010, the FDA approved the new Norvir tablet
Norvir® (ritonavir) is in a class of medicines called the HIV protease (PRO-tee-ase)
inhibitors. Norvir is used in combination with other anti-HIV medicines to treat people
with human immunodeficiency virus (HIV) infection. Norvir is for adults and for
children age greater than one month and older.
Norvir does not cure HIV infection or AIDS and does not reduce the risk of passing
HIV to others. People taking Norvir may still get opportunistic infections or other
conditions that happen with HIV infection. Some of these conditions are pneumonia,
herpes virus infections, and Mycobacterium avium
complex (MAC) infections.
Important Safety Information
People who have had a serious allergic reaction to Norvir or any of its ingredients
should not take Norvir. Allergic reactions ranging from hives, asthma, severe
breathing issues and mild to severe skin reactions have occurred.
The below list of drug interactions is not complete. Before people take Norvir, they
must tell their doctor about all the medicines they are taking or are planning to take.
These include other prescription and non-prescription medicines, and herbal
People should not take the following medicines with Norvir because they can
cause serious or life-threatening problems
such as irregular heartbeat, breathing
difficulties or excessive sleepiness: Cordarone® (amiodarone); ergotamine,
ergonovine, methylergonovine, and dihydroergotamine such as Cafergot®, Migranal®,
D.H.E. 45® and others; Halcion® (triazolam); Orap® (pimozide); Propulsid® (cisapride);
quinidine, also known as Quinaglute®, Cardioquin®, Quinidex® and others; Revatio®
(sildenafil) only when used for the treatment of pulmonary arterial hypertension;
Rythmol® (propafenone); Tambocor® (flecainide); Uroxatral® (alfuzosin hydrochloride);
Vascor® (bepridil); Versed® (oral midazolam); and Vfend® (voriconazole).
People should not take Norvir with St. John's wort (Hypericum perforatum)
may decrease Norvir levels and lead to increased viral load and possible resistance to
Norvir or other antiretroviral medicines.
People should not take Norvir with Mevacor® (lovastatin) or Zocor® (simvastatin)
because of possible serious reactions. There is an increased risk of drug interactions
between Norvir and Lipitor® (atorvastatin) and Crestor® (rosuvastatin); people should
talk to their doctor before they take any of these cholesterol-lowering medicines with
For people taking Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil) with
Norvir, their doctor may lower their dose of these medicines because they may be at
risk of side effects such as low blood pressure, visual changes and penile erection
lasting more than four hours. People should tell their doctor right away if they
Women taking oral contraceptives ("the pill") or using the contraceptive patch to
prevent pregnancy should use a different type of contraception since Norvir may
reduce the effectiveness of oral or patch contraceptives.
For people taking Mycobutin® (rifabutin), their doctor will lower the dose of Mycobutin.
Norvir oral solution contains alcohol. People should talk with their doctor if they are
taking or planning to take Flagyl® (metronidazole) or Antabuse® (disulfiram). Severe
Rifampin, also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®, may reduce
blood levels of Norvir. People should tell their doctor if they are taking rifampin.
Rifampin and saquinavir should not be taken together with Norvir. People should tell
their doctor if they are taking rifampin and saquinavir.
People taking or about to begin inhaled Flonase® (fluticasone propionate), Serevent®
(salmeterol), or Advair® (salmeterol in combination with fluticasone propionate) should
talk to their doctor about problems these medicines may cause when taken with
Norvir. Their doctor may choose not to keep them on inhaled Flonase®, Serevent® or
Side Effects (This list is not complete):
Blood tests in patients taking Norvir® (ritonavir) may show possible liver problems.
People with liver disease such as hepatitis B and C who take Norvir may have
worsening liver disease. Liver problems, including death, have occurred in people
who take Norvir and in people taking Aptivus® (tipranavir) with Norvir. People should
tell their doctor right away if they have any of the following signs and symptoms: loss
of appetite, yellowing of skin or eyes (jaundice), dark-colored urine, pale-colored
stools, itchy skin and/or stomach area (abdominal) pain.
Pancreas problems (pancreatitis) which may cause death have been reported in
some people taking Norvir. People should tell their doctor if they have nausea,
vomiting or abdominal pain as these may be signs of pancreatitis.
Large increases in triglycerides and cholesterol have occurred in some people taking
Norvir. The long-term chance of getting complications such as heart attacks or stroke
due to increases in triglycerides and cholesterol caused by protease inhibitors is not
Diabetes and high blood sugar (hyperglycemia), changes in body fat and increased
bleeding in people with hemophilia have occurred in some people taking protease
inhibitors including Norvir. People should tell their doctor if they notice an increase in
thirst or urinate often. The cause and long-term effects of body fat changes are not
Changes in the electrocardiogram (EKG) can occur when taking Norvir. People
should consult their physician if they experience dizziness, lightheadedness, fainting
spells or abnormal heartbeat. People with heart defects or conduction defects should
Immune reconstitution syndrome may occur after starting anti-HIV medicines,
including Norvir. This happens when people develop signs and symptoms of serious
infections they already have or had, which may require additional treatment.
The most commonly reported side effects are feeling weak/tired, nausea, vomiting,
diarrhea, loss of appetite, abdominal pain, changes in taste, tingling feeling or
numbness (in hands, feet or around the lips), headache, and dizziness.
For women who are pregnant or planning to become pregnant, it is not known if
Norvir can harm their unborn baby. Women taking Norvir while they are pregnant
should talk to their healthcare professional about how they can take part in the
Antiretroviral Pregnancy Registry. Mothers taking Norvir should not breast-feed
because they may pass HIV on to their baby, or their baby could experience side
The long-term effects of Norvir are not known at this time.
Please for Norvir full Prescribing Information.
Kaletra® (lopinavir/ritonavir) is a prescription anti-HIV-1 medicine called a protease
inhibitor that contains lopinavir and ritonavir. Kaletra is used with other anti-HIV-1
medicines to increase the chance of treatment response in people with human
immunodeficiency virus (HIV-1) infection. It is not known if Kaletra is safe and
effective in children under 14 days old.
Kaletra does not cure HIV-1 infection or AIDS and does not reduce the risk of passing
HIV-1 to others. People taking Kaletra may still get opportunistic infections or other
Important Safety Information
Kaletra should not be taken by people who are allergic to Kaletra or any of its
ingredients, including lopinavir or ritonavir.
The list of drug interactions below is not complete. People must tell their doctor about
all medicines they are taking or planning to take, including those without a
prescription, vitamins, and herbal products.
Serious problems or death can happen taking these medicines with Kaletra:
ergot-containing medicines, including ergotamine (Cafergot® and others),
dihydroergotamine (D.H.E. 45® and others), ergonovine (Ergotrate®), and
methylergonovine (Methergine®); triazolam (Halcion®); midazolam oral syrup;
pimozide (Orap®); lovastatin (Mevacor®); simvastatin (Zocor®); rifampin (Rimactane®,
Rifadin®, Rifater®, or Rifamate®); sildenafil (Revatio®) only when used for the
treatment of pulmonary arterial hypertension; or products containing St. John’s wort
The following medicines may need changes when taken with Kaletra:
control pills that contain estrogen (“the pill”), birth control (contraceptive) patches,
atorvastatin (Lipitor®), rosuvastatin (Crestor®), efavirenz (Atripla® and Sustiva®),
nevirapine (Viramune®), amprenavir (Agenerase®), fosamprenavir (Lexiva®), nelfinavir
(Viracept®), phenytoin (Dilantin®), carbamazepine (Tegretol®), phenobarbital, sildenafil
(Viagra®), tadalafil (Cialis®), vardenafil (Levitra®), rifabutin (Mycobutin®), inhaled
fluticasone (Flonase®), salmeterol (Serevent®) and salmeterol in combination with
There is an increased risk of certain problems when taking medicines such as
®), tadalafil (Cialis
®), or vardenafil (Levitra
®) with Kaletra,
because the interaction with these medicines may result in an increase in their side
effects, such as low blood pressure (dizziness or fainting), vision changes, and/or
erections lasting more than 4 hours. People should tell their doctor right away if they
Kaletra oral solution contains a large amount of alcohol. People should talk with their
doctor if they take or plan to take metronidazole (Flagyl®) or disulfiram (Antabuse®).
They can have severe nausea and vomiting if they take these medicines with Kaletra.
Kaletra may not be right for everyone. People should tell their doctor about all
their medical conditions.
Changes in heart rhythm and electrical activity of the heart
can occur when
taking Kaletra. These changes can lead to serious heart problems. The risk for these
problems may be higher for people who already have a history of abnormal heart
rhythm or other types of heart disease, or if they take other medicines that can affect
their heart rhythm while taking Kaletra. People should tell their doctor right away if
they experience dizziness, lightheadedness, fainting and/or a sensation of abnormal
, including death, can happen in people who take Kaletra. Blood
tests in people who take Kaletra may show possible liver problems. People with liver
disease such as hepatitis B or C who take Kaletra may have worsening liver disease.
People should tell their doctor right away if they have any of the following signs and
symptoms: loss of appetite, yellowing of skin or eyes (jaundice), dark-colored urine,
pale-colored stools, itchy skin and/or stomach area (abdominal) pain.
Inflammation of the pancreas (pancreatitis)
, which may be serious and cause
death, has occurred in some people who take Kaletra. People have a higher chance
of having pancreatitis if they have had it before. People should tell their doctor if they
have nausea, vomiting, and/or abdominal pain, as these may be signs of pancreatitis.
Immune reconstitution syndrome
may occur after starting anti-HIV medicines,
including Kaletra. This happens when people develop signs and symptoms of serious
infections they already have, which may require additional treatment.
Large increases in certain fat (triglycerides and cholesterol) levels in the blood
have occurred in some people receiving Kaletra. The long-term chance of getting
complications such as heart attacks or strokes due to these increases in triglycerides
and cholesterol caused by protease inhibitors is not known at this time.
New or more serious diabetes and high blood sugar (hyperglycemia)
occurred in some people who take protease inhibitors, including Kaletra. People
should tell their doctor if they notice an increase in thirst or urinate often while taking
Changes in body fat
have been seen in some people who take anti-HIV therapy.
The cause and long-term health effects of these conditions are not known at this time.
Increased bleeding has occurred in some people with hemophilia
Women taking birth control pills or using patches to prevent pregnancy should use an
extra form or a different type of birth control since birth control pills or patches may
not work as well while taking Kaletra. Women should talk to their doctor about how to
It is not known if Kaletra will harm unborn babies. Women who are pregnant or
planning to become pregnant should tell their doctor.
Women taking Kaletra during pregnancy should talk with their doctor about how they
can take part in an Antiretroviral Pregnancy Registry. The purpose of the pregnancy
registry is to follow the health of the mother and their baby.
Women should not breast-feed while taking Kaletra. There is a chance that HIV can
be passed to the baby through breast milk and their baby may have serious side
Common side effects of Kaletra
include diarrhea, nausea, stomach area
(abdominal) pain, feeling weak, vomiting, headache and upset stomach. These are
not all of the possible side effects of Kaletra.
The long-term effects of Kaletra are not known at this time.
Please for Kaletra full Prescribing Information.
Abbott is a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics. The company employs more than
72,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's
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