FDA Law Blog

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form.

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Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. For new or generic drugs to work in a patient, they must, of course, be made correctly by using Current Good Manufacturing Practices. and other high-income countries.

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FDA Law Blog

MAY 26, 2022

As we noted in a previous post , FDA’s first (of fourteen) legislative proposal targets 180-day generic drug exclusivity, stating: Amend the 180-Day Exclusivity Provisions to Encourage Timely Marketing of First Generics. I) Effectiveness of application.-Subject

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The Pharma Data

DECEMBER 28, 2020

This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020.

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Drug Channels

FEBRUARY 23, 2021

Despite these responses, more than half of payers believe that cost containment strategies should not limit patients’ ability to receive access to appropriate care. Hence, the American Hospital Association wrote to CMS to “express deep concerns” about UnitedHealthcare’s white bagging policies for provider-administered specialty drugs.

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FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v.

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FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v.

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Delveinsight

FEBRUARY 5, 2021

Some of these approved products contain nicotine as an active ingredient, while others do not. Moreover, the generic drugs of Zyban are also approved, while for Chantix, its patent is soon going to expire in 2021 in the EU and in 2022 in Japan. Generics in the Market. Smoking Cessation Emerging Therapies.

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Druggist

MARCH 17, 2021

Lymecycline is usually prescribed as a generic drug – lymecycline 408mg capsules or occasionally as a branded medication called Tetralysal 300 mg capsules. Both drugs are the same medicines. Benzoyl peroxide is sold to treat acne from pharmacies as a branded product called Acnecide 5% gel.

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Druggist

MARCH 25, 2021

Cerelle and Cerazette are two brands of daily progestogen-only pill (POP), also known as mini-pill. In recent years prescribing of Cerazette in NHS decreased, in place of other brands, including Cerelle. Do generic, and branded drugs produce exactly the same effect? . How can I get Cerazette pill? Cerazette**.

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Druggist

OCTOBER 13, 2020

Truvada is a brand name of a combination drug, which contains two antiviral medicines: emtricitabine and tenofovir disoproxil. One important message to take away is that Truvada and equivalent generic drugs are not 100% effective. There are several generic versions of Truvada.

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The Pharma Data

OCTOBER 14, 2020

The company’s Specialty Brands reportable segment’s areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. © 2020 10/20.

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The Pharma Data

MAY 4, 2021

On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.

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Pharmaceutical Technology

DECEMBER 4, 2022

Citing studies comparing such products, there are no important differences between biosimilars and their branded counterpart, says Arnold Vulto, PharmD, professor of hospital pharmacy at Erasmus University, Rotterdam. Also, some biosimilars contain citrate, while others like Abrilada do not.

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Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya legal drama.

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. For example, Tailored Brands, the parent of Men’s Wearhouse and K & G, have declared they may have to file for bankruptcy protection, joining almost 7,000 other companies that filed for Chapter 11 bankruptcy protection last year. Drugs and Vaccines.

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