Sentences with phrase «approved drug labeling»

Not exact matches

While it's not approved specifically for anti-aging treatments, like other drugs, it can be prescribed for so - called off - label uses as long as there is no advertising or efficacy claims involved.

She said Janssen has acted responsibly regarding its opioid pain medications, which are approved by the U.S. Food and Drug Administration and carry FDA - mandated warnings on their labels about the drugs» known risks.

However, lawsuits and allegations suggest that perhaps up to 80 % of Subsys prescriptions were being written for off - label indications, which is a no - no, and that Insys» sales team was being less than forthright in angling physicians toward the drugs» approved indication.

There is nothing wrong with using an approved drug for an off label usage.

However, the U.S. Food and Drug Administration has not approved Sudafed for the purpose of ending milk production, which is considered an «off - label» use of the medication.

While many drugs are used off - label for other indications, it is important to note that domperidone is not approved for any indication in the United States.

For example, the FDA recently approved new labeling information for trimethoprim / sulfamethoxazole (Septra ®), emphasizing the need for caution in administering this drug to nursing women, particularly if the infant is jaundiced, ill, stressed, or premature, because of the potential risk for bilirubin displacement and kernicterus.

At the same time the papers supported unvetted «off - label» uses for HRT that were not approved by drug regulators, including healthier skin, protection against Alzheimer's and Parkinson's diseases, and a generally higher quality of life.

The U.S. Food and Drug Administration originally approved the drug in 1999, but subsequent case reports of abnormal behavior in adolescents who used the medication led the agency in 2006 to require that all packaging of the drug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self - harm and even suicDrug Administration originally approved the drug in 1999, but subsequent case reports of abnormal behavior in adolescents who used the medication led the agency in 2006 to require that all packaging of the drug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self - harm and even suicdrug in 1999, but subsequent case reports of abnormal behavior in adolescents who used the medication led the agency in 2006 to require that all packaging of the drug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self - harm and even suicdrug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self - harm and even suicide.

Without dedicated drugs, doctors sometimes resort to off - label practice — prescribing a medication approved for a different ailment.

Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved, although the labeling of the generic risperidone might differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity, the agency said.

Scientific knowledge and new findings go far beyond data sets produced from clinical trials, often are outside the scope of the parameters established by the Food and Drug Administration regulations, and often outdate the FDA - approved labeling.»

[1] This includes information gathered before and after a drug is approved that is not included on the label.

The process they have followed in order to gather the specific information was to extract from the published literature all pharmacogenomic biomarkers that relate to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved drugs with pharmacogenomic information in their label and make them available in a database that triangulates between drugs, genes and pharmacogenomics biomarkers.

According to the researchers, more research is needed to determine if off - label use of antipsychotic medications yields substantial clinical benefit and to identify how doctors decide to prescribe these drugs for non-FDA approved conditions.

Label the FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patLabel the FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patlabel is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient.

Off - Label Use a drug prescribed for conditions other than the indication (s) for which it was approved by the FDA.

Drug Labels FDA drug labels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingredieDrug Labels FDA drug labels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingredLabels FDA drug labels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug labels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingredlabels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug tolerance or dependency, and a list of drug ingrediedrug ingredients.

And no drug, whether approved or off - label, can help you with the long - term commitment you need.»

«A pill can make a person less hungry, but it cant tell them how to eat,» says Michael Anchors, MD, who holds a patent on Phen - Pro, an off - label weight - loss combo that blends the FDA - approved weight - loss drug phentermine along with an antidepressant like Prozac.

Next Page: Off - label: Other antidepressants [pagebreak] Off - label: Other antidepressants Doctors often prescribe drugs off - label to treat medical conditions; this means they prescribe a drug to treat a condition for which it has not been approved by the FDA but has shown promise in practice.

Memantine, also known by its brand name, Namenda, is approved by the Food and Drug Administration (FDA) only for moderate - to - severe cases of Alzheimer's, although doctors often prescribe it «off - label» for milder cases of the disease.

In recent years, the Food and Drug Administration (FDA) has approved several of the drugs as an add - on medication for depression and autism, and research shows that doctors commonly prescribe them «off - label» (i.e., without the FDA's official blessing) for a wide range of conditions, including anxiety, ADHD, post-traumatic stress disorder (PTSD), and even insomnia.

This is an off label usage of the drug, but there is currently no approved microlifaricide.

On Day 0, dogs received a single treatment of the appropriate drug according to approved commercial label.

A main benefit of an FDA - approved nonsteroidal anti-inflammatory drug for dogs or cats is that it has been shown to be safe and effective in that species when used according to the label.

MADISON, New Jersey, January 23, 2012 — The Food and Drug Administration (FDA - CVM) has approved a new product label for Convenia ® (cefovecin sodium), the single - injection cephalosporin for treatment of common canine and feline bacterial skin infections.

While Paxil isn't approved by the FDA for use in animals, vets are able to legally prescribe it as an «off label» drug use.

Currently Approved Labels for Companion animal Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

MADISON, NJ — May 31, 2012 — Pfizer Animal Health announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for CERENIA ® (maropitant citrate), the only FDA approved veterinary antiemetic medication.

The term «off label» describes the use of a drug for conditions other than what it was approved for.

Another leading cause of drug residue violations is when producers use a product outside of its FDA - approved label.

However, many if not most of the psychiatric medications given to pets are being used off - label - that is, for conditions other than the ones that the drugs were approved to treat.

In practice, it is usually the first approved indication that is free of exclusivity protection earlier in time and generics, while submitting drug applications for an early market entry, carve out the subsequent indications from the label to avoid potential infringement of patents which may cover the new approved indications.

J & J's Janssen unit, however, is adamant that unlike what Pledger's family and other plaintiffs are claiming, the medication's Food and Drug Administration - approved label did properly warn about the possible risks.

The FDA has also approved Pradaxa to treat pulmonary embolisms and deep vein thrombosis, and the drug is used for off - label purposes that are not FDA - approved.

Zofran is an anti-nausea drug that was originally approved for patients undergoing surgery or cancer treatment, but has been often prescribed «off - label» (a use other than what was approved by the FDA) to treat morning sickness during pregnancy.

It also would have required pharmacies to label compounded drugs to indicate that the FDA had neither inspected nor approved the drug, required reporting of adverse reactions to compounded drugs, and created a public «Do Not Compound» list.

Off Label Prescription Drugs — use for all approved drugs - for individual, small and large groups includingDrugs — use for all approved drugs - for individual, small and large groups includingdrugs - for individual, small and large groups including HMOs

Researched and developed drug - disease database to facilitate integration of prescriptions into episodes of care; mapped over 2,000 drug names to ICD - 9 and CPT codes corresponding to approved and off - label indications

Doctors may also prescribe prescription drugs for off - label use — purposes which the drugs were not originally approved for by the regulatory agency.

However, the study researchers, led by Mark Olfson of Columbia University, discovered that in nearly 90 percent of the cases, the drugs are being used «off label» to treat conditions for which they've never been approved.

In the U.S., IUDs are not approved by the Food and Drug Administration for use as emergency contraception; this would be an off - label use.

But many drugs that may have narrow conditions of approved use are often prescribed off - label by physicians when they have data and information about how effective they can be for other conditions where not much else works.