FDA Approves Entresto

July 7, 2015 — The U.S. Food and Drug Administration today approved Entresto(sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.

Entresto

Generic Name: sacubitril and valsartan
Date of Approval: July 7, 2015
Company: Novartis Pharmaceuticals Corporation

In clinical trials, Entresto was shown to significantly reduce the rate of heart failure deaths and hospitalizations compared to the ACE inhibitor enalapril.The U.S. Food and Drug Administration (FDA) has approved Entresto (sacubitril/valsartan), a neprilysin inhibitor and angiotensin receptor blocker (ARB) combination used to reduce the risk of hospitalization and cardiovascular death in patients with chronic heart failure. Entresto tablets are available in three dosage strengths administered twice daily, usually in conjunction with other heart failure therapies.

PATIENT INFORMATION

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

IMPORTANT INFORMATION

Entresto can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. If you get pregnant during treatment, tell your doctor right away.

WHAT IS ENTRESTO?

Entresto is a prescription medicine used to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure.It is usually used with other heart failure therapies, in place of an ACE inhibitor or other ARB therapy.Heart failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body.It is not known if Entresto is safe and effective in children.

WHO SHOULD NOT TAKE ENTRESTO?

Do not take Entresto if you:

• are allergic to sacubitril or valsartan or any of the inactive ingredients. See the end of this Patient Information leaflet for a complete list of ingredients.
• have had an allergic reaction including swelling of your face, lips, tongue, throat or trouble breathing while taking a type of medicine called an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB).
• take an ACE inhibitor medicine. Do not take Entresto for at least 36 hours before or after you take an ACE inhibitor medicine. Talk with your doctor or pharmacist before you start treatment if you are not sure if you take an ACE inhibitor medicine.
• have diabetes and take a medicine that contains aliskiren.

BEFORE TAKING ENTRESTO

Before you start treatment, tell your doctor about all of your medical conditions, including if you:

• have kidney or liver problems
• are pregnant or plan to become pregnant. See Important information.
• are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You and your doctor should decide if you will take Entresto or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Entresto with other medicines can cause serious side effects. Especially tell your doctor if you take:

• potassium supplements or a salt substitute
• nonsteroidal anti-inflammatory drugs (NSAIDs)
• lithium
• other medicines for high blood pressure or heart problems such as an ACE inhibitor, ARB, or aliskiren Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

HOW SHOULD I TAKE ENTRESTO?

• Take this medicine exactly as your doctor tells you to take it.
• Take your dose two times each day. Your doctor may change your dose during treatment.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you overdose, call your doctor right away.

ENTRESTO SIDE EFFECTS

Entresto may cause serious side effects including:

• See Important information.
• Serious allergic reactions causing swelling of your face, lips, tongue, and throat (angioedema) that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take Entresto again if you have had angioedema during treatment. Black patients may have a higher risk of having angioedema during treatment. People who have had angioedema prior to treatment may have a higher risk of having angioedema during treatment. See Who should not take Entresto?
• Low blood pressure (hypotension). Low blood pressure may be more common if you also take water pills. Call your doctor if you become dizzy or lightheaded, or you develop extreme fatigue.
• Kidney problems. Your doctor will check your kidney function during your treatment.If you have changes in your kidney function tests, you may need a lower dose, or may need to stop treatment for a period of time.
• Increased amount of potassium in your blood. Your doctor will check your potassium blood level during treatment.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE ENTRESTO?

• Store Entresto at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect the tablets from moisture.
• Store the tablets in the original container.

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF ENTRESTO

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information leaflet summarizes the most important information. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN ENTRESTO?

Active ingredients: sacubitril and valsartan

Inactive ingredients: microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate (vegetable origin), talc, and colloidal silicon dioxide.
Film coat: hypromellose, titanium dioxide (E 171), Macrogol 4000, talc, iron oxide red (E 172). The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black (E 172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E 172).

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FDA Approves Odomzo

Odomzo (sonidegib) Capsules

Company: Novartis Pharmaceuticals Corporation
Date of Approval: July 24, 2015
Treatment for: Basal Cell Carcinoma

Odomzo is the second hedgehog pathway inhibitor approved for the treatment of basal cell carcinoma.

The U.S. Food and Drug Administration (FDA) has approved Odomzo (sonidegib), an oral hedgehog pathway inhibitor for the treatment of locally advanced basal cell carcinoma (laBCC) that has returned after surgery or radiation therapy, or for patients who cannot undergo surgery or radiation therapy. It joins Erivedge (vismodegib) as the second hedgehog pathway inhibitor approved for the treatment of basal cell carcinoma.

MEDICATION GUIDE

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

IMPORTANT INFORMATION

Odomzo can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

For females who can become pregnant:

• You should talk to your healthcare provider about the risks to your unborn child.
• Your healthcare provider will do a pregnancy test before you start treatment.
• In order to avoid pregnancy, you should use birth control during treatment, and for at least 20 months after your final dose. Talk to your healthcare provider about what birth control method is right for you during this time.
• Talk to your healthcare provider right away if you have unprotected sex or if you think your birth control has failed.
• Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

For males:

• It is not known if Odomzo is present in semen. Do not donate semen while you are taking Odomzo and for at least 8 months after your final dose.
• You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment and for at least 8 months after your final dose to protect your female partner from being exposed to Odomzo.
• Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Odomzo.

Exposure to Odomzo during pregnancy:

If you think that you or your female partner may have been exposed to Odomzo during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment, you or your healthcare provider should report your pregnancy to Novartis Pharmaceuticals Corporation at 1-888-669-6682.

WHAT IS ODOMZO?

Odomzo is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has come back following surgery or radiation or that cannot be treated with surgery or radiation.

It is not known if it is safe and effective in children.

BEFORE TAKING ODOMZO

Before you take Odomzo, tell your healthcare provider if you:

• have muscle pain or spasms, or have a history of a muscle disorder called rhabdomyolysis or myopathy
• have any other medical conditions
• are pregnant or plan to become pregnant. See Important information.
• are breastfeeding or plan to breastfeed. It is not known if Odomzo passes into your breast milk. Do not breastfeed during treatment and for 20 months after your final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

HOW SHOULD I TAKE ODOMZO?

• Take this medicine exactly as your healthcare provider tells you.
• Take Odomzo one time each day, at least one hour before or two hours after a meal.
• If you miss a dose, skip the missed dose. Take your next dose as scheduled.

WHAT SHOULD I AVOID WHILE TAKING ODOMZO?

• Do not donate blood or blood products during treatment and for 20 months after your final dose.
• Do not donate semen during treatment and for at least 8 months after your final dose.

ODOMZO SIDE EFFECTS

Odomzo can cause serious side effects, including:

• See Important information.
• Muscle Problems. Muscle spasms and muscle pain are common with Odomzo, but can also sometimes be symptoms of serious muscle problems. Odomzo can increase your risk of muscle pain and, rarely a serious condition caused by injury to the muscles (rhabdomyolysis) that can lead to kidney damage. Tell your healthcare provider right away if you develop any new or worsening muscle spasms, pain or tenderness, dark urine, or decreased amount of urine during treatment.

Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking Odomzo, during treatment, and if you develop muscle problems.

The most common side effects include:

• hair loss
• change in taste
• tiredness
• nausea
• diarrhea
• weight loss
• decreased appetite
• vomiting
• stomach area (abdominal pain)
• itching
• headache

Odomzo can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE ODOMZO?

• Store at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF ODOMZO

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN ODOMZO?

Active ingredient: sonidegib

Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer, and sodium lauryl sulfate. The capsule shell contains gelatin, red iron oxide, and titanium dioxide. The black printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.

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FDA Approves Daklinza

Daklinza (daclatasvir) Tablets

Company: Bristol-Myers Squibb Company
Date of Approval: July 24, 2015
Treatment for: Chronic Hepatitis C

Daklinza in combination with sofosbuvir is the first 12-week, once-daily, all-oral treatment regimen for patients with chronic hepatitis C virus (HCV) genotype 3.

The U.S. Food and Drug Administration (FDA) has approved Daklinza (daclatasvir), an NS5A replication complex inhibitor indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection.

PATIENT INFORMATION

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

IMPORTANT INFORMATION

Daklinza is used in combination with the antiviral medicine sofosbuvir (Sovaldi).

You should not take Daklinza alone to treat chronic hepatitis C infection.

You should also read the Patient Information for sofosbuvir (Sovaldi).

WHAT IS DAKLINZA?

• Daklinza is a prescription medicine used with sofosbuvir to treat chronic (lasting a long time) hepatitis C genotype 3 infection in adults.
• Daklinza should not be taken alone.

It is not known if this medicine is safe and effective in children under 18 years of age.

BEFORE TAKING DAKLINZA

Before taking Daklinza, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems other than hepatitis C infection
• have had a liver transplant
• have heart problems
• are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Daklinza may affect the way other medicines work, and vice versa, which may cause side effects.

Keep a list of your medicines to show your healthcare provider and pharmacist.

• You can ask your healthcare provider or pharmacist for a list of medicines that interact with Daklinza.
• Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Daklinza with other medicines.

HOW SHOULD I TAKE DAKLINZA?

• Take Daklinza exactly as your healthcare provider tells you to.
• Do not change your dose unless your healthcare provider tells you to.
• Do not stop treatment without first talking with your healthcare provider.
• Take Daklinza one time each day with or without food.
• If you miss a dose, take the missed dose as soon as you remember the same day. Take the next dose at your regular time.
• If you miss a dose and remember the next day, skip the missed dose. Take the next dose at your regular time.
• Do not take two doses at the same time to make up for the missed dose.
• If you exceed your prescribed dose, call your healthcare provider or go to the nearest hospital emergency room right away.

DAKLINZA SIDE EFFECTS

Daklinza in combination with sofosbuvir and amiodarone may cause serious side effects, including:

• Slow heart rate (bradycardia). Daklinza combination treatment with sofosbuvir may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone, a medicine used to treat certain heart problems. Get medical help right away if you take amiodarone with sofosbuvir and Daklinza and get any of the following symptoms:
  • fainting or near-fainting
  • weakness
  • chest pain
  • dizziness or lightheadedness
  • tiredness
  • confusion
  • not feeling well
  • shortness of breath
  • memory problems

The most common side effects of Daklinza when used in combination with sofosbuvir include:

• headache
• tiredness

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE DAKLINZA?

• Store Daklinza at room temperature between 68°F and 77°F (20°C and 25°C).

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF DAKLINZA

It is not known if treatment with Daklinza will prevent you from infecting another person with the hepatitis C virus during treatment. Talk with your healthcare provider about ways to prevent spreading the hepatitis C virus.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN DAKLINZA?

Active ingredient: daclatasvir

Inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green. Opadry green contains hypromellose, titanium dioxide, polyethylene glycol 400, FD&C blue #2/indigo carmine aluminum lake, and yellow iron oxide.

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New Drug Approval Process

FDA Approvals

It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.

If the FDA gives the green light, the “investigative” drug will then enter three phases of clinical trials:

• Phase 1 uses 20-80 healthy volunteers to establish a drug’s safety and profile. (about 1 year)
• Phase 2 employs 100-300 patient volunteers to assess the drug’s effectiveness. (about 2 years)
• Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)

The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.

The research-based pharmaceutical industry currently invests some US$12.6 billion a year in new drug development. Historically, the drug development figure doubles every five years.

Steps from Test Tube to New Drug Application Review

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FDA Takes Action Against Unapproved Prescription Ear Drop Products

July 1, 2015

The U.S Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation.

The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status.

In a federal register notice published today, the agency informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. Today’s action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.

Unapproved prescription otic drug products containing the following ingredients are covered by this action:

• benzocaine
• benzocaine and antipyrine;
• benzocaine, antipyrine, and zinc acetate;
• benzocaine, chloroxylenol, and hydrocortisone;
• chloroxylenol and pramoxine; and
• chloroxylenol, pramoxine, and hydrocortisone.

“Taking enforcement actions against these unapproved products will protect patients from unnecessary risks,” said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “There are many FDA-approved prescription products to treat ear infections, so we expect little or no impact on patients from the removal of these unapproved and potentially unsafe products.”

Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.

Companies making and selling unapproved otic drug products covered by this action that are not currently listed with the FDA must stop manufacturing and shipping the products immediately. Companies that wish to market the drug products covered by this action can submit a new drug application (NDA) or an abbreviated new drug application (ANDA) for the FDA to consider approval of these products.

Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternatives. Today’s action is part of the FDA’s Unapproved Drugs Initiative, which seeks to reduce consumer exposure to drugs that are not proven to be safe, effective and of high quality.

Consumers and health care professionals are encouraged to report adverse events or medication errors from the use of unapproved prescription products to the FDA’s MedWatch Adverse Event Reporting Program.

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Source: FDA

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FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms

 U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors.An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement — like eating, writing and shaving.

Essential tremor affects several million people and usually occurs in those over age 40. “There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new device adds to the array of treatment options to help people living with Parkinson’s and essential tremor enjoy better, more productive lives.”The Brio Neurostimulation System consists of a small (1.9in x 2.1in x 0.4in) battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed within the brain at specific locations depending on whether the device is being used to treat Parkinson’s disease or essential tremor. The electrical pulse generator continuously delivers low intensity electrical pulses to target areas in the brain. Health care providers make adjustments to the pulse generator to optimize the effects of the Brio Neurostimulation System.

Data supporting the safety and effectiveness of the device system included two clinical studies. One study included 136 patients with Parkinson’s disease and the other included 127 patients with essential tremor. In both studies, patients had symptoms, including tremors, that were not adequately controlled with drug therapy.The Brio Neurostimulation System was used in addition to medication for patients with Parkinson’s disease and the majority of patients with essential tremor who used the device were able to control their symptoms without the need for medications. Researchers implanted the Brio Neurostimulation System in all patients and assessed effectiveness for Parkinson’s disease patients at three months and essential tremor patients at six months. Both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on compared to when it was turned off.

Serious adverse events included intracranial bleeding, which can lead to stroke, paralysis or death. Other device-related adverse events included infection and dislocation of the device lead under the skin. The Brio Neurostimulation System is manufactured by St. Jude Medical in St. Paul, Minnesota.

Brio Neurostimulation System is the second device approved by the FDA for Parkinson’s and essential tremor. The first device, Medtronic’s Activa Deep Brain Stimulation Therapy System, was approved in 1997 for tremor associated with essential tremor and Parkinson’s disease. In 2002, the indications were expanded to include the symptoms of Parkinson’s disease.In its early stages, Parkinson’s disease typically affects one side of the body and starts as problems with movement, stiffness, and mild tremors. Gradually, the symptoms can affect both sides of the body and medications may become less effective. People with late stage Parkinson’s disease have many symptoms including: trouble walking, impaired posture and balance, muscle stiffness and tremors in the arms and hands that make it difficult to perform everyday tasks.

Essential tremor most often affects the hands and arms and can be slowly progressive, starting on one side of the body but eventually affecting both sides. Hand tremor is the most common symptom, but tremors can also affect movement in the head, arms, voice, tongue, legs, and trunk. About half of essential tremor cases result from a genetic mutation. For the remainder of cases, the cause is unknown.

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