Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). Outlook stated that ONS-5010 will get 12 years of regulatory exclusivity in the US if it is approved by the FDA.

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The Checkup by Singlecare

DECEMBER 30, 2024

If liquid gabapentin is needed, a provider at a compounding pharmacy must prepare it. Additionally, gabapentin is typically used as a human medicine; its prescribed off-label for dogs since it doesnt have FDA approval for them yet. However, the human liquid version should not be given to dogs.

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The Checkup by Singlecare

DECEMBER 12, 2024

Ozempic is also sometimes prescribed off-label (for a non-FDA-approved use) as a weight loss drug. With the popularity of glucagon-like peptide 1 receptor agonists ( GLP-1 agonists ) like Ozempic, you may have seen advertisements for compounded semaglutide. That includes compounded semaglutide.

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The Checkup by Singlecare

FEBRUARY 14, 2025

It is also commonly prescribed off-label (for non-FDA-approved use) to help with weight loss and weight management in people with obesity or who are overweight with weight-related medical conditions. Enter compounding pharmacies , which create compounded versions of drugs like tirzepatide.

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The Checkup by Singlecare

APRIL 4, 2025

Food and Drug Administration (FDA) to treat Type 2 diabetes and lower the risk of cardiovascular events and kidney problems in certain adults. Semaglutide injections may also be used off-label for weight management. The injectable medicine, Ozempic, is approved by the U.S.

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The Checkup by Singlecare

MARCH 7, 2024

Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.

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The Checkup by Singlecare

MARCH 25, 2024

Unlike Ozempic, which is FDA approved to treat Type 2 diabetes, Wegovy is approved for weight loss in patients with a body mass index (BMI) of 30 or higher and in patients with a BMI of 27 or higher who also have a weight-related medical condition like Type 2 diabetes, high blood pressure, or high cholesterol.

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The Checkup by Singlecare

APRIL 17, 2024

Mounjaro (tirzepatide) is an injectable medication prescribed for Type 2 diabetes mellitus, which some doctors may prescribe off-label for weight loss. At first glance, Mounjaro might look pretty pricey, but its out-of-pocket costs can vary drastically based on insurance coverage, discounts, pharmacy location, and more.

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The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

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The Checkup by Singlecare

FEBRUARY 14, 2025

However, regular pharmacies don’t make them. Instead, special compounding pharmacies create these medications. As a result, they’re not the same as medicines approved by the Food and Drug Administration (FDA). When FDA-approved GLP-1s are hard to find, compounded versions can fill the gap.

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The Checkup by Singlecare

APRIL 19, 2024

Ciprofloxacin is a broad-spectrum antibiotic that veterinarians may use off-label in dogs. Food and Drug Administration (FDA) for use in dogs and cats. There are no veterinary formulations of ciprofloxacin except those prepared by a compounding pharmacy. Ciprofloxacin is a fluoroquinolone antibiotic.

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The Checkup by Singlecare

FEBRUARY 13, 2025

When this happens, compounding pharmacies (such as those that work with telehealth companies ) are able to make formulations of a drug that is not readily available. Although compounded versions of tirzepatide, the active ingredient in Zepbound, are becoming popular online, the two drugs are not exactly the same.

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The Checkup by Singlecare

JANUARY 6, 2025

Ozempic (semaglutide) is a brand-name drug made by Novo Nordisk and approved by the Food and Drug Administration (FDA) to help treat Type 2 diabetes. It is also prescribed off-label for weight loss. Compounded semaglutide is a medication thats custom-made for you by a compounding pharmacy.

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The Checkup by Singlecare

MARCH 21, 2024

Nonetheless, healthcare providers may prescribe it off-label for weight loss. Its active ingredient, semaglutide, is FDA approved for weight loss under the brand name Wegovy , which has a dosing progression of 0.25 Ozempic can be effective across all dosages for weight loss, but higher doses saw better results. mg, 1 mg, 1.7

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The Checkup by Singlecare

FEBRUARY 13, 2025

It was approved by the Food and Drug Administration (FDA) in 2022 to help control blood sugar levels in adults with Type 2 diabetes , but healthcare providers often prescribe this medicine off-label (for a non-FDA-approved use) for weight loss in people with obesity (or overweight with certain medical conditions).

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The Checkup by Singlecare

FEBRUARY 8, 2024

For dogs, veterinarians prescribe it off-label to control seizures, manage chronic pain or nerve pain , and control anxiety. Gabapentin is not FDA-approved for use in dogs, so all uses are off-label uses. Gabapentin is prescribed off-label for dogs. That means the FDA has not approved its use in dogs.

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The Thyroid Pharmacist

JUNE 30, 2023

You may be familiar with naltrexone, which is an FDA-approved medication that has been used since the 1980s for opioid withdrawal. Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. It needs to be compounded into lower doses by a professional compounding pharmacy.

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The Checkup by Singlecare

FEBRUARY 1, 2024

Gabapentin is not FDA approved for use in pets, but veterinarians often use it off-label to calm a cat before stressful events such as a vet visit. The FDA has not approved the use of gabapentin in cats. When veterinarians prescribe gabapentin for cats, they do so off-label. This may be too large of a dose for a cat.

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The Checkup by Singlecare

FEBRUARY 8, 2024

Although it’s approved for use in humans, its veterinary use is off-label , that is, the U.S. Food and Drug Administration (FDA) has not approved tramadol for veterinary medicine. Alternatively, a compounding pharmacy can make smaller-dose tablets or an oral solution. Do not use kitchen utensils or tableware.

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The Checkup by Singlecare

MARCH 28, 2024

For this reason, its use in dogs is off-label. So, read labels carefully. Pet parents will use tablets made for humans or mirtazapine custom-made by a compounding pharmacy. However, a veterinarian may supply mirtazapine in a liquid format made by a compounding pharmacy. mg, 15 mg, 30 mg, and 45 mg.

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The Checkup by Singlecare

APRIL 19, 2024

Food and Drug Administration (FDA) has not approved the veterinary use of amitriptyline, so all these treatments are considered off-label uses. Urinary bladder inflammation Amitriptyline is commonly used off-label in humans to treat bladder inflammation (interstitial cystitis). Amitriptyline addresses all three.

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The Checkup by Singlecare

APRIL 15, 2024

The FDA has not approved cetirizine for use in animals, so only give your dog cetirizine under the direction of a veterinarian. However, extra-label use of antihistamines like cetirizine includes any itch involving histamines , such as allergic reactions , insect bites , or hives. Compounding pharmacies are another source.

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The Checkup by Singlecare

JANUARY 6, 2025

Buspirone is not FDA-approved for use in cats and dogs, so its use in veterinary medicine is off-label. If dosing is too difficult, a compounding pharmacy can supply a transdermal patch, but its not considered very effective. The expiration date is written on the label. They seem to be a normal part of being a cat.

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The Checkup by Singlecare

FEBRUARY 6, 2025

Lisinopril is not FDA-approved for use in dogs or other animals, so all veterinary use of the medication is off-label. Veterinary pharmacies typically sell generic or relabeled versions of lisinopril tablets made for people. Veterinary pharmacies typically sell generic or relabeled versions of lisinopril tablets made for people.

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The Checkup by Singlecare

JULY 30, 2024

mg/kg single intravenous injection Lorazepam is not FDA-approved for animal use, so pet owners will use human-formulated versions or lorazepam specially formulated by a compounding pharmacy. Because lorazepam is used off-label in dogs and hasn’t been well-studied, veterinary literature does not specify a maximum dosage.

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The Checkup by Singlecare

APRIL 19, 2024

Food and Drug Administration (FDA)for use in dogs —the canine version is called Reconcile—but its use in cats is off-label. These drugs work by increasing the serotonin levels in the body, which aids in decreasing anxiety and impulsiveness. Fluoxetine is approved by the U.S. Follow all the veterinarian’s instructions.

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The Checkup by Singlecare

MARCH 6, 2024

The veterinary use of omeprazole in dogs is off-label , meaning the U.S. Food and Drug Administration (FDA) does not approve it for this use. The veterinarian or a compounding pharmacy can also supply an oral suspension for easier dosing. Omeprazole belongs to a class of drugs called proton pump inhibitors , or PPIs.

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The Checkup by Singlecare

DECEMBER 12, 2024

Semaglutide has become a very popular drug thats in high demand in pharmacies everywhere and is currently also available from compounding pharmacies and online. But not all compounded semaglutide products are safe. Heres what to know about buying semaglutide from a compounded pharmacy or online.

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The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Does insurance cover compounded semaglutide? affected by a shortage).

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The Checkup by Singlecare

NOVEMBER 13, 2024

It’s also commonly prescribed off-label for weight loss. Some people have tried cheaper alternatives like compounded semaglutide, but these options may not always be safe or trustworthy. This means no drugmakers are producing a true generic version of Ozempic that’s approved by the Food and Drug Administration (FDA).

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The Checkup by Singlecare

FEBRUARY 13, 2025

It is approved by the Food and Drug Administration (FDA) for weight loss and long-term weight management in adults and adolescents 12 years and older with obesity , as well as adults who are overweight and have at least one weight-related health condition, such as high cholesterol or Type 2 diabetes. What is compounded semaglutide?

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The Checkup by Singlecare

MAY 24, 2024

Its use in cats is “off-label,” meaning that the U.S. Food and Drug Administration ( FDA ) has not approved the drug for use in companion animals. Treatment lasts only a few days, with relatively minimal potential side effects. When cats have problems, they usually involve gastrointestinal issues like nausea or diarrhea.

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The Checkup by Singlecare

FEBRUARY 25, 2025

Lisinopril is not FDA approved for use in cats, so veterinarians prescribe lisinopril off-label. Pet owners will have to use tablets made for people or tablets prepared by a compounding pharmacy. A compounding pharmacy or veterinary pharmacy can specially prepare a liquid version of lisinopril made with oil.

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The Checkup by Singlecare

FEBRUARY 11, 2025

As an anxiety medication, pregabalin is FDA approved in cats for the alleviation of situational anxiety, particularly travel anxiety or veterinary visits. Veterinarians may also use pregabalin off-label to relieve chronic pain or prevent seizures, but they prefer to use other medications for these problems.

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Omnicell

SEPTEMBER 5, 2022

Worst yet, 74% of all respondents were aware of at least one pharmacy compounding error in the last 12 months. Our coalition is focused on championing the universal use of automated IV workflow management systems in compounding pharmacies. • Auto Bar-Code Labeling produced only for final preparations.

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The Checkup by Singlecare

DECEMBER 13, 2024

Pregabalin is not approved for use in dogs, so its use in veterinary medicine is off-label. Pregabalin is not FDA-approved for use in dogs. However, the FDA has approved a pregabalin solution for use in cats. Pharmacies do carry lower-priced generic versions. Can dogs overdose on pregabalin?

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The Checkup by Singlecare

FEBRUARY 3, 2025

mg/kg given by mouth once or twice a day For proteinuria: 0.251 mg/kg given by mouth once or twice a day For hypertension: 0.251 mg/kg given by mouth once or twice a day Benazepril is not approved by the Food and Drug Administration (FDA) for use in animals. Benazepril tablets for people start at 5 mg.

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