FDA Law Blog

APRIL 8, 2024

This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. In a display of the competition within the generic industry that keeps margins low , this total included 118 new drug applications and 956 generic drug applications.

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FDA Law Blog

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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Pharma in Brief

APRIL 25, 2021

As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g.,

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The following is a general summary of some of the highlights from the proposed amendments discussed in the Notice of Intent. Biologic Drugs.

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Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. QbD as an aspect of process and analytical methods.

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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. Teva’s patents do not meet that criterion.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § 355(j)(2)(A)(v).

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Camargo

DECEMBER 9, 2020

Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US. This effectively “evergreens” the product, preventing generic competition. Unapproved Drug Initiative Ends.

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Druggist

SEPTEMBER 30, 2020

Buscopan and mebeverine are two common drugs used for symptomatic treatment of irritable bowel syndrome (IBS). Both drugs can be prescribed by a doctor or purchased over the counter from pharmacies and in case of Bucopa IBS relief from supermarkets. Buscopan vs Mebeverine lists similarities and differences between both drugs.

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Drug Channels

FEBRUARY 23, 2021

Let’s melt away this foul February with our monthly selection of scorching news from around the drug channel. Despite these responses, more than half of payers believe that cost containment strategies should not limit patients’ ability to receive access to appropriate care. The battle for specialty drug margin rages on.

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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.

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Drug Channels

MARCH 15, 2022

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S. drug pricing, reimbursement, and dispensing system. d/b/a Drug Channels Institute. The 2022 Economic Report on U.S.

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The Pharma Data

DECEMBER 28, 2020

Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.”

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FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Do you really have to identify both “Grants” to be correct?

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pharmaphorum

AUGUST 24, 2020

She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment. Container Closure Integrity Evaluation: USP Perspective. • A Sustainable, Ecological and Efficient rFC Endotoxin Testing Solution.

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Pharma in Brief

JANUARY 9, 2022

In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Drug Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

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XTalks

JUNE 16, 2023

The ongoing chemotherapy drug shortage is a critical situation impacting cancer care in the US. The two drugs are often used in combination to treat many types of cancer, including lung, breast and prostate cancers, as well as many leukemias and lymphomas​​.

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Druggist

MARCH 17, 2021

Lymecycline is a drug, which belongs to a group of tetracycline antibiotics. 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. Why is lymecycline used in the treatment of acne?

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The Pharma Data

DECEMBER 4, 2021

“The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. You are encouraged to report side effects of prescription drugs to the FDA. About Teva.

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The Pharma Data

JANUARY 17, 2021

Clinical validation of transdermal and sublingual drug formulations. Psychedelic API production, drug formulation and clinical integration. Drug Formulations and Delivery. Vektor also successfully developed a sublingual drug formulation on contract for a major generic drug manufacturer and distributor.

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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

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Generics in the Market.

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Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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The Pharma Data

JANUARY 27, 2021

Construction of commercial drug manufacturing facility in Germany. Psychedelic transdermal and sublingual drug formulation development. Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.

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Druggist

MARCH 25, 2021

Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen).

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The Pharma Data

OCTOBER 14, 2020

Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt , visit www.mallinckrodt.com. and foreign tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws.

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Druggist

OCTOBER 13, 2020

Truvada (emtricitabine/tenofovir disoproxil) is an antiviral drug used in the treatment of HIV, alone or as part of antiviral combination therapy. Truvada is a brand name of a combination drug, which contains two antiviral medicines: emtricitabine and tenofovir disoproxil. Today, I am reviewing Truvada for PrEP.

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir.

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The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. Cautionary Note on Forward-Looking Statements. Source link.

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The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorbrena (lorlatinib) — In March 2021, Pfizer announced that the U.S.

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XTalks

AUGUST 30, 2022

The pharmaceutical industry deals with threats such as product liability, cyberthreats, supply chain disruptions, competition from generic drugs and more. Although these leadership styles are of very different natures, they also contain some commonalities. Therefore, strategic intent is vital when making decisions.

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Pharmaceutical Technology

JANUARY 6, 2023

In this most recent settlement, the drug company faced allegations of colluding with the generics company Par Pharmaceuticals to violate antitrust laws. Novartis has also been on the receiving end of litigation with the Greek health ministry, academic institutes, and more, engaging the drug company in other legal disputes.

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Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. While small molecule drugs can be remade into identical generics, biologics are more complex. Also, some biosimilars contain citrate, while others like Abrilada do not.

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Drugs and Vaccines. The most promising news about any drug thus far in the pandemic just came out of the UK where Southampton researchers together with Synairgen showed that an inhaled form of interferon-? Drugs, Vaccines and Masks. percent in 2021.

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