The FDA Law Blog

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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Pharmaceutical Companies Pharmaceutical Companies FDA 59

The Checkup by Singlecare

FEBRUARY 22, 2024

Food and Drug Administration (FDA) extended its prior approval of Xolair (omalizumab) to treat accidental exposure to food allergens. Xolair is not a new drug; it was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in some patients. 16, the U.S. What is Xolair? RN, the CEO of FARE.

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pharmaphorum

JUNE 7, 2021

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. The approval of aducanumab, now given the name Aduhelm, comes after a three-month extension to the FDA’s review period.

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FDA 89

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.

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The FDA Law Blog

SEPTEMBER 19, 2023

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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FDA Communication Dosage 105

Hospital Pharmacy Europe

APRIL 27, 2023

A 2003 study suggested that 5-alpha reductase inhibitors (5-ARIs) such as finasteride, prevent or delay the appearance of prostate cancer. However, the FDA warned in 2011 that 5-ARIs may increase the risk of a more serious form of prostate cancer. million new cases in 2020.

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Hospitals FDA 98

Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. Zydus, which currently has 360 approvals, has filed abbreviated new drug applications for more than 440 drugs since 2003-04.

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FDA Immunization Vaccines 52

PharmaShots

APRIL 13, 2023

Through the inclusion of Pharmacia’s products along with a strong performance, Pfizer’s pharmaceutical and animal health revenue was boosted by 40% and 43% respectively In the year 2003, Johnson & Johnson generated a revenue of $41.9B which depicted a growth of 15.3% as compared to the previous year. from last year.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Labelling 40

pharmaphorum

NOVEMBER 20, 2022

The FDA subsequently raised serious concerns about the accuracy of testing that Theranos did conduct with its machines, and the company eventually retracted two years of blood tests before folding in 2018. “She knew that it could not successfully compete with the established conventional machines.”

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FDA 122

pharmaphorum

DECEMBER 16, 2020

The license agreement will help advance the development of ABBV-47D11, which in pre-clinical research demonstrated potential against SARS-CoV-2, as well as the related SARS-CoV-1 virus that caused an outbreak in Asia in 2003. Regeneron and Eli Lilly have been leading the charge to develop antibody-based therapies against the coronavirus.

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Hospitals FDA 98

pharmaphorum

JANUARY 27, 2022

Biogen and Eisai have increased the earning potential of their Alzheimer’s drug Aduhelm by expanding the post-marketing trial of the drug required by the FDA – which could be the primary source of income for the drug.

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FDA Labelling Insurance 81

The Checkup by Singlecare

APRIL 17, 2024

Food and Drug Administration (FDA) approved Wegovy for adults and children 12 years and older who have a body mass index (BMI) of 30 or higher or who have a BMI of 27 or higher with a related medical condition, such as high blood pressure, Type 2 diabetes, or high cholesterol.

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Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

NOVEMBER 4, 2020

As an influential panel of FDA-appointed experts prepares its verdict on Biogen’s Alzheimer’s drug, a little known China-based pharma is hoping to succeed where big name rivals have failed and develop a drug that is effective against the disease.

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FDA 74

The Checkup by Singlecare

NOVEMBER 15, 2024

Additionally, the FDA hasn’t listed any known interactions for the medications on the losartan or amlodipine labels. An older study on amlodipine from 2003 concluded that it’s best to take antihypertensive agents in the morning, claiming it was better for circadian blood pressure than evening administration.

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People Management Labelling FDA 52

The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

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Documentation FDA Labelling 52

pharmaphorum

MAY 24, 2022

Vaccines used during the smallpox eradication programme can provide around 85% protection against monkeypox, according to the WHO, which notes that one newer vaccine – Bavarian Nordic’s Jyneos – has been approved by the FDA for prevention against both viruses. The US FDA also approved a new intravenous form of the drug last week.

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Vaccines FDA Labelling 95

The Checkup by Singlecare

JANUARY 20, 2023

Food and Drug Administration (FDA), generic medications cost 80%-85% less than brand-name drugs. Chances are, you’ve taken a generic or authorized generic medication, and for good reason—according to the U.S. An estimated 90% of prescriptions filled in the United States are for commonly prescribed generic drugs.

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Prescription Filling Dosage FDA Labelling 98

The Checkup by Singlecare

DECEMBER 15, 2023

Food and Drug Administration (FDA) when proper dosage is followed. Food and Drug Administration (2003) The post Does Zyrtec make you drowsy? How to use Zyrtec safely Zyrtec is considered safe by the U.S. Always follow the instructions on the label for accurate dosing. appeared first on The Checkup.

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Pharmacy Program Director Dosage Labelling FDA 116

ISPE

SEPTEMBER 15, 2022

First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. Thomas Zimmer, PhD. 15 September 2022. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. 12 of February 2020 again received 2,000 comments from public consultation.

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Documentation FDA 97

Pharmaceutical Technology

SEPTEMBER 23, 2022

Dry eye syndrome (DES) is an indication whose mainstay treatment has been dominated by Allergan’s Restasis (cyclosporine ophthalmic emulsion 0.05%) ever since its launch in 2003 in the US. Novaliq/ Bausch + Lomb’s NOV-3 (perfluorohexyloctane) is also currently at pre-registration stage with the FDA. Novaliq’s CyclASol (0.1%

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FDA 59

The Checkup by Singlecare

APRIL 17, 2024

Legislation passed in 2003 prohibits Medicare from covering drugs prescribed specifically for weight loss, and while Medicaid has more flexibility here, not every state will cover them. I tried to prescribe Mounjaro, which helps with heart failure and diabetes, but I couldn’t get it covered.”

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Insurance Insurance Coverage Compounding Pharmacies Compounding 98

The Checkup by Singlecare

NOVEMBER 14, 2024

For example, it’s FDA approved to treat soreness and joint pain from inflammatory conditions like rheumatoid arthritis and osteoarthritis, and research shows it’s effective in the short-term. Some older studies—like this one from 2003 —have concluded that ibuprofen can relieve exercise-induced soreness in the short term.

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FDA 97

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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Compounding Pharmacies Insurance Insurance Coverage Compounding 93

The Checkup by Singlecare

OCTOBER 20, 2023

In another small 2003 study where researchers placed participants into two groups—a placebo group and a shilajit receiving group—the researchers found a decrease in cholesterol and triglyceride levels in the shilajit group. Supplements are not regulated by the Food and Drug Administration (FDA), so contamination is possible.

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Immunization FDA 105

European Pharmaceutical Review

OCTOBER 19, 2023

we must prove the effectiveness of radiopharmaceuticals through clinical trials… This has been demonstrated recently with PLUVICTO… the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer” At this moment, there is no single treatment for cancer today.

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Chemotherapy Compounding Immunization FDA 105

The FDA Law Blog

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. This means that there multiple same-day FDA NDA approvals for the same drug. FDA-2020-E-1840 (Mar.

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FDA Controlled Substances Hospitals 59

pharmaphorum

MARCH 2, 2022

A recent publication showcased that the number of active clinical trials running that are researching various psychedelic therapies has increased rapidly from 2003 to 2021. With promising pre-clinical and clinical stage results, there are more and more therapeutic candidates being developed in this space.

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Compounding FDA 105

ISPE

APRIL 13, 2023

1 More recently, regulators like the FDA have increasingly promoted the benefits of modeling (e.g., Topics in Chemical Engineering, 2003. Biopharma Adopts Mechanistic Modeling Mechanistic modeling has been widely used in the petrochemical industry for many decades, while biochemical producers have been slower to adopt. Melton, and E.

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Compounding FDA 98

pharmaphorum

OCTOBER 27, 2021

This year has been marked by one of the biggest developments in the search for new treatments for Alzheimer’s disease, after the US FDA approval of Biogen’s Aduhelm (aducanumab) in June. The monoclonal antibody was the first new drug to be approved for Alzheimer’s since 2003.

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The FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. And FDA still hasn’t said a thing! In fact, federal law and regulation appear to require AbbVie to list these patents.”

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Dosage FDA 45

STAT

JULY 6, 2023

Both are run by a husband-and-wife team that has received more than $17 million in NIH funding since 2003, according to the animal rights group. The company said it had started rolling submission of data for the shot with the FDA and is aiming to be the third vaccine maker to get an approval in the country after GSK and Pfizer.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 77

PharmaShots

APRIL 20, 2023

Food and Drug Administration (FDA) in June 2020 as a rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. On October 14, 2022, the FDA approved Lyumjev® (insulin lispro-aabc injection), a rapid-acting mealtime insulin, for the treatment of children with diabetes.

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FDA Insurance Labelling 40

The Checkup by Singlecare

FEBRUARY 1, 2024

Food and Drug Administration (FDA) to treat opioid use disorder and alcohol use disorder. Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Naltrexone , also known by its brand-name counterpart Vivitrol, is approved by the U.S. It comes as an oral tablet and intramuscular (IM) injection.

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Communication Dosage FDA 92

pharmaphorum

JANUARY 4, 2022

Stanford University drop-out Holmes founded Theranos in 2003 when she was just 19, and at its height the company was worth $9 billion, with its founder feted as the next Steve Jobs. Theranos raised almost $1 billion from investors before the company and its claims were eventually exposed as a sham.

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Documentation Communication FDA 52

Pharmaceutical Technology

SEPTEMBER 22, 2022

AstraZeneca ’s cholesterol drug Crestor (rosuvastatin) was approved in 2003 in the US but only approved in Germany in 2008. In 2013, the FDA first approved Vazkepa solely for the reduction of triglyceride levels for hypertriglyceridemia. Following this, in 2019, the FDA approved Vazkepa for the reduction of cardiovascular risk.

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Pharmaceutical Companies Pharmaceutical Companies FDA Dosage 52

The People's Pharmacy

MAY 1, 2023

The FDA first approved brand name omeprazole as prescription Prilosec in 1989. The agency was so sure this acid-suppressing drug was benign that the agency approved Prilosec OTC in 2003. Millions of people take these drugs to control acid reflux, ulcers or gastroesophageal reflux disease (GERD).

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Hospitals FDA 64

The Checkup by Singlecare

JUNE 11, 2024

Zepbound is an injectable medication that is FDA approved for weight management in adults with obesity. In fact, coverage of obesity medications was banned by the Medicare Modernization Act of 2003. It works by reducing cravings and overeating, contributing to weight loss.

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Insurance Insurance Coverage Mail-Order Pharmacies Dosage 59