The FDA Law Blog

JANUARY 18, 2024

Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market. By John W.M.

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The FDA Law Blog

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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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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pharmaphorum

JANUARY 9, 2023

The transaction will be effected by means of a UK scheme of arrangement under Part 26 of the UK Companies Act 2006, subject to approval of Amryt shareholders, sanction by the High Court of Justice of England and Wales, and other customary closings, including regulatory/antitrust approvals.

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The Checkup by Singlecare

NOVEMBER 15, 2024

In a study from 2006 , researchers called the combination of amlodipine and losartan “an excellent option for the treatment of a wide range of hypertensive patients.” Additionally, the FDA hasn’t listed any known interactions for the medications on the losartan or amlodipine labels.

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The FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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The FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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pharmaphorum

OCTOBER 13, 2020

EUSA Pharma , at number 39, already has cancer drugs on the market and has FDA regulatory clearance for a stage 3 clinical trial testing its siltuximab drug in COVID-19 after showing an increase in patient survival rates.

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Pharmaceutical Technology

MARCH 22, 2023

Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format. In recent times, various global administrators have issued regulatory standards.

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pharmaphorum

MAY 27, 2022

First launched in 2006, Roblox is an online space where users can play games – more than 20 million of them at a recent count – created by developers and individuals. The platform is used mainly by children under 16, the group most likely to be affected by ADHD and a target demographic for Akili’s therapy.

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Pharmaceutical Technology

JULY 29, 2022

Janssen’s Risperdal (risperidone), a second-generation antipsychotic , got its first FDA approval for autism-related irritability for children over the age of five, in 2006.

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European Pharmaceutical Review

MARCH 6, 2023

On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. Since 2006, he has held leadership positions in the neuroscience area at Eli Lilly and in epidemiology at GlaxoSmithKline.

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pharmaphorum

DECEMBER 28, 2022

These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. She joined NSF in 2017.

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pharmaphorum

SEPTEMBER 30, 2022

Viatris is seeking FDA approval to market generic versions of both Januvia and Janumet in the US. First launched in 2006, sales of Januvia and its line extensions have remained reasonably strong despite increasing pressure in the type 2 diabetes market and price pressures, particularly in international markets. The US patent (No.

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European Pharmaceutical Review

SEPTEMBER 21, 2023

The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years. Internet] FDA. For example, market access authorisation comes with a requirement to monitor patients for much longer than traditional medicines. In Europe, the EMA requires up to a 15-year follow up of patients. cited 2023August].

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European Pharmaceutical Review

NOVEMBER 4, 2022

Based on these results, Athenex filed for a new drug application (NDA) with the US Food and Drug Administration (FDA), but in early 2021 the company received a Complete Response Letter from FDA, citing various concerns including an “increase in neutropenia-related sequelae” in the Oraxol arm. References. Hennenfent K, Govindan R.

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The Checkup by Singlecare

SEPTEMBER 11, 2024

Food and Drug Administration ( FDA ) to treat major depressive disorder (depression) in adults, and it is sometimes used off-label as an appetite stimulant. A small 2006 study concluded that mirtazapine was associated with significantly increasing body weight, body fat mass, and leptin concentration.

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Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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pharmaphorum

MARCH 3, 2021

Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009. In July 2020, Kindeva was added as a defendant in the action. 3M was voluntarily dismissed from the case. A further approval in 2017 in childhood asthma has helped the drug to build sales in the US.

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European Pharmaceutical Review

AUGUST 23, 2022

The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. World Health Organization; 2006. References. Counterfeit medicines. Available from: [link]. The Guardian. Fake drugs kill more than 250,000 children a year, doctors warn. 2019; Available from: [link].

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pharmaphorum

NOVEMBER 22, 2021

In late 2006, BRAVEMIND was tested in San Diego, California, at the Naval Medical Center and Camp Pendleton, and good clinical data was obtained in the initial open clinical trials. Other groups started to adopt the platform, which led to more research as to its clinical efficacy.

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pharmaphorum

FEBRUARY 23, 2022

In both the European Union (EU) and the US, biosimilars do not have a particularly long history on the market, with the first of such products approved in the EU in 2006 and in the US in 2015. The short story so far.

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The Checkup by Singlecare

OCTOBER 11, 2023

Phenylephrine In September 2023, the FDA announced that a common decongestant found on shelves, phenylephrine, is not actually effective to decrease congestion. American College of Obstetricians and Gynecologists (2021) FDA clarifies results of recent advisory committee meeting on oral phenylephrine , U.S. Here’s what to skip.

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pharmaphorum

OCTOBER 4, 2021

Turning to the CD28 programme, the company acknowledged this has been a challenging target, referring to TeGenero’s notorious attempt to develop an agonist antibody against it – called theralizumab – which left patients fighting for their lives in a phase 1 trial in 2006.

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pharmaphorum

SEPTEMBER 18, 2020

In 1990, the US Food and Drug Administration (FDA) requested Astra to change Losec’s brand name to Prilosec, to avoid confusion with Sanofi-Aventis’ diuretic, Lasix (furosemide). Since 2006, AstraZeneca found itself in various disputes over generic versions of Nexium, which has patents due to expire in 2015.

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PharmaShots

MARCH 29, 2023

Lupin has earned the US FDA approval for the generic version of Banzel as Rufinamide Oral Suspension. Last year TWI announced the US FDA approval of their generic Dexilant is available in 30mg and 60mg capsules which would be released into the market once the patents expire. The exact mechanism of action is uncertain.

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The Checkup by Singlecare

DECEMBER 5, 2023

Levothyroxine (a thyroid hormone) is FDA approved to treat hypothyroidism , a condition in which the body produces less thyroid hormone than your body needs. It’s FDA approved to treat attention-deficit/hyperactivity disorder (ADHD) symptoms, including inattention, hyperactivity, and impulsivity.

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The Checkup by Singlecare

JULY 17, 2023

The generic form of Zoloft became available in 2006 and is a more affordable option. Food Drug Administration (FDA) , a generic medicine works in the same way and provides the same clinical benefit as brand-name medicine. The FDA Generic Drugs Program conducts a rigorous review to ensure generic drugs meet standards.

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The People's Pharmacy

APRIL 10, 2023

The FDA has established the maximum daily dose at 4,000 mg. That could be too high for some people ( JAMA , July 5, 2006 ). We have never understood why drug companies and the FDA have not seriously entertained this idea. Other suggestions include limiting the number of APAP pills dispensed in a single bottle or box.

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pharmaphorum

DECEMBER 21, 2021

However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs. Headway being made.

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The Checkup by Singlecare

FEBRUARY 10, 2025

Food and Drug Administration (FDA) approved Januvia in 2006. While no generic version of Januvia is currently available, a generic version of sitagliptin is available under a different brand name: Zituvio, which received FDA approval in 2023. However, Zituvio is not a generic equivalent of Januvia.

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Pharmaceutical Technology

OCTOBER 5, 2022

However, Biogen was able to bring Tysabri back to the market in 2006, after providing evidence that the benefits of the drug outweighed its risk. Tecfidera was approved in 2013 to treat MS, and in August 2020, Mylan launched its first FDA-approved dimethyl fumarate generic to the market.

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PharmaShots

APRIL 13, 2023

Its subsidiary, DePuy's CHARITE Artificial Disc for degenerative disc disease was the first device to be approved by the US FDA By acquiring Roche’s OTC business, Bayer was able to strengthen its consumer health business. by the sales of Humira 2006 Johnson & Johnson recorded global sales of $53.3B

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PharmaShots

FEBRUARY 21, 2023

In Aug’21, the US FDA cleared QSam’s IND application for CycloSam. In Jun’21, the company initiated the evaluation of FAP-2286 in a P-I/II clinical trial (LuMIERE) following the US FDA’s IND clearance. In Sep’21, the US FDA granted DUNP19 an ODD for Osteosarcoma.

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The Checkup by Singlecare

FEBRUARY 6, 2025

Food and Drug Administration ( FDA ) in 1991 as the brand-name medication Zocor. It wasnt until 2006 that the generic version was released. Simvastatin is a generic medication that is produced by various pharmaceutical companies. It was first approved by the U.S.

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The FDA Law Blog

AUGUST 29, 2024

That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S.

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BuzzRx

JANUARY 29, 2023

Keeping Sudafed products behind the counter, along with other regulations, was mandated by the FDA in 2006 because pseudoephedrine, the main ingredient in Sudafed products, can be used illegally to make methamphetamine. To make a purchase, you must be at least 18 years old with a valid form of photo ID.

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