The FDA Law Blog

AUGUST 10, 2022

Koblitz — For years , FDA has been wrestling with questions about what patents should be listed in the Orange Book, but, as we have reported, FDA has made little to no progress on addressing those questions. One of those pressing questions that remains unanswered involves the listing of REMS patents in the Orange Book.

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pharmaphorum

AUGUST 3, 2022

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. Roche has US marketing rights to the drug, and booked $1.3

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pharmaphorum

JULY 11, 2021

In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. In the letter, she writes: “FDA’s decisions are far ranging and it is inevitable that some of those decisions will lead to controversy.”

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pharmaphorum

JANUARY 10, 2022

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. The main side effects listed on its label are headache and – unsurprisingly – sleepiness.

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Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

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The Thyroid Pharmacist

DECEMBER 28, 2022

Knowing there were others who also had thyroid conditions, and wanting to spread the message, I decided to summarize my research and improvements in my book, Hashimoto’s: The Root Cause, in 2013. When it leaks into the bloodstream, the body does not recognize it, and labels the structure as a foreign invader and attacks it.

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The Checkup by Singlecare

JULY 24, 2023

Food and Drug Administration (FDA), like prescription and OTC drugs are. A 2017 study published in the Journal of Clinical Sleep Medicine , which examined 31 different melatonin supplements, found that 71% of the supplements studied had a dosage that did not match what was listed on the label.

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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 is used at a higher, standard dose of 50 mg per day. LDN is truly an intriguing drug.

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The Thyroid Pharmacist

OCTOBER 7, 2022

Sure enough, she read all the labels on her supplements and in her pantry, and gave her kitchen a stevia-free makeover. Steviol glycosides, which are refined extracts of stevia, are recognized as safe by the Food and Drug Administration (FDA). If you haven’t read my book Hashimoto’s Protocol yet, you may wish to pick up a copy!

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Pharma Marketing Network

JUNE 11, 2020

We may do some things like you were talking about where we have advertorials, and it’s clearly labeled as an advertorial. And do that, you interviewed me back in 2015, for the results book. I think that’ll be a big piece of what we do then, just overall, in terms of the industry suppliers that are out there.

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The FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. GSK skinny label case , the U.S. The Government’s concern goes far beyond this case: Like many generic drug sponsors, the Government raises concerns of the implications of the outcome of this case on the skinny label pathway itself.

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pharmaphorum

MARCH 13, 2022

The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to its PARP inhibitor crown. billion in sales for AZ last year, a rise of around 25%, while Merck booked just under $1 billion from the drug.

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pharmaphorum

NOVEMBER 30, 2021

The FDA will deliver a verdict on AstraZeneca’s PARP inhibitor Lynparza as an adjuvant treatment for breast cancer in the first quarter of next year, after granting the application a priority review. billion in sales for AZ last year, while Merck booked $725 million from the drug. million new cases per year.

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The FDA Law Blog

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. FDA Commissioner Robert M. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. By Kalie E. Califf, M.D.

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The People's Pharmacy

MAY 29, 2023

The drug also affects the brain, which is why the FDA has approved clonidine for attention deficit hyperactivity disorder (ADHD). To learn more about this under-recognized problem we suggest either our Guide to Drugs and Older People or the chapter on senior citizens in our book Top Screwups Doctors Make and How to Avoid Them.

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The Thyroid Pharmacist

JULY 14, 2023

Here’s an excerpt from my book, Hashimoto’s Protocol : Most physicians and endocrinologists will say that in Hashimoto’s, hypothyroidism is irreversible and ends with complete thyroid cell damage, leading to a lifelong requirement of thyroid hormone medications. They may also help with circulation, skin healing, inflammation, and more!

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The Checkup by Singlecare

OCTOBER 12, 2023

Abilify generic | Abilify vs. aripiprazole | Cost | Off-label use | How to switch Abilify is a brand-name medication approved to treat certain mental health conditions, including the treatment for schizophrenia , bipolar disorder , and major depressive disorder. Abilify first received FDA approval in 2002. mL, 960 mg/3.2

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The Thyroid Pharmacist

SEPTEMBER 12, 2022

Resorcinol is restricted in all cosmetics in Japan, and the EU limits concentrations and requires warning labels. To avoid this chemical, look for the following ingredients on your product labels: resorcinol, 1,3-benzenediol, resorcin, 1,3-dihydroxybenzene (m-hydroxybenzene, m-dihydroxyphenol). The Problem.

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The Checkup by Singlecare

MAY 2, 2024

The survey, which was published in his book ADHD After Dark , focused on couples consisting of one partner with ADHD and the other without the condition. Irwin Goldstein, MD , a urologist and the director of San Diego Sexual Medicine, said he often prescribes Adderall off-label to women with sexual dysfunction “with great success.”

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The People's Pharmacy

JUNE 26, 2023

When she died, she had just been put on an antidepressant with a black-box FDA suicide warning. Many years ago, in our book, Graedons’ Best Medicine (1991), we wrote about the evolution of Prozac: “When Prozac (fluoxetine) was introduced in 1987 it barely made a splash. Therapy sessions turned into 15 minute “med checks.”

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pharmaphorum

JANUARY 8, 2021

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We pic.twitter.com/ZDtIjm1z8W. — Dr Katrina Farrell (@farrell_katrina) December 31, 2020. Internationally, the decision has been met with scepticism.

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pharmaphorum

JANUARY 8, 2021

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We pic.twitter.com/ZDtIjm1z8W. — Dr Katrina Farrell (@farrell_katrina) December 31, 2020. Internationally, the decision has been met with scepticism.

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The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA.

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PharmaShots

MARCH 9, 2023

Since its launch in 2016, Tivic Health has obtained three regulatory clearances for ClearUP, including FDA 510(k), FDA De Novo, and CE Mark, four patents, and numerous awards. Present company and time period: Labcorp (32 yrs. LinkedIn Total experience: 37 yrs. Present company and time period: Stryker Corporation (25 yrs.)

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The Thyroid Pharmacist

OCTOBER 27, 2023

Precautions Do not take more than the recommended dose on the label. If you’re experiencing these symptoms, reduce your dosage to ⅛ teaspoon daily, increasing usage slowly, as tolerated, to get to the recommended label usage. The usual recommended dose of ibuprofen is 200 mg; do not exceed 1200 mg in 24 hours.

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The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression.

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pharmaphorum

APRIL 22, 2022

Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development.

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The Thyroid Pharmacist

FEBRUARY 10, 2023

You can learn more about this in my book, Adrenal Transformation Protocol. After doing the targeted interventions outlined in my adrenal program and book, many of my clients have reported feeling more like “themselves” and even see major improvements in symptoms that had been with them for decades, in just two to four weeks.

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The Thyroid Pharmacist

JULY 20, 2023

I love my friend Jolene’s book Is this Normal? I also love the book Period Repair Manual by Lara Briden and Fix Your Period by Nicole Jardin. A reinvestigation using Fe-labelling and non-invasive liver iron quantification. 58] FDA approves first oral treatment for anemia caused by chronic kidney disease for adults on dialysis.

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The Thyroid Pharmacist

JANUARY 20, 2023

It has been 10 years since I wrote my first book on Hashimoto’s, yet at the time of writing, there was no “official research” to connect stress to Hashimoto’s and hypothyroidism. I love using adrenal adaptogens, especially during my own peak periods of stress (did someone say, “holidays” or “book deadline”?)

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The FDA Law Blog

JANUARY 1, 2025

Teva , the generic industry has feared the death of the skinny label (admittedly stoked by alarmist headlines like my own, see Ding Dong is the Skinny Label (Effectively) Dead? ). The safe harbor applies only when the labeling, promotion, or commercial marketing does not reference the condition(s) of use claimed in the patent.

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The Thyroid Pharmacist

NOVEMBER 15, 2024

Blood sugar balance is such a big deal in Hashimoto’s that a blood sugar-balanced diet is a foundation for most of my Hashimoto’s protocols I share on my website, in my programs, and in my books. Ozempic is a GLP-1 agonist and is actually marketed as a diabetes drug, but many physicians are prescribing it for weight loss (off label-use).

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The People's Pharmacy

MAY 4, 2023

The FDA has not approved its use to prevent or treat heart attacks. This would be considered an off-label use. She discusses her latest book, The Anti-Viral Gut: Tackling Pathogens from the Inside Out. Doctors routinely prescribe colchicine to prevent and treat gout attacks. By the way, colchicine is a very old drug.

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