FDA Approval, Generic Drugs, Marketing and Research

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

FDA Approval

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FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S.

Insulin

Insulin Production FDA Approval Generic Drugs

Drug labeling authority, UDI program reviewed by Harvard-based researchers

The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

Drugs

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The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.

Marketing

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Expanding ketamine’s horizons to treat rare neurological disorders

Pharmaceutical Technology

NOVEMBER 29, 2022

For several decades, researchers have been investigating the role of ketamine in treating depression. In 1970, the FDA approved ketamine as an anesthetic. Depression research spurs efforts for other conditions. Ketamine-induced neuroplasticity is one of the key areas of research at the moment, says Kohtala.

Research

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Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. That word “same” is hard to answer when it comes to prescription drugs.

FDA Approval

FDA Approval Branding Pharmacy Manufacturing

Top 40 Best-Selling Oncology Drugs in 2023 by 2022 Data

XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. This analysis not only highlights the financial success of these drugs but also sheds light on the therapeutic advancements and innovation driving patient outcomes in the oncology domain.

FDA Approval

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The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

Generic Drugs

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The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

Generic Drugs

Generic Drugs Drugs Branding Production

Top 40 Best-Selling Cancer Drugs in 2023 by 2022 Data

XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. This analysis not only highlights the financial success of these drugs but also sheds light on the therapeutic advancements and innovation driving patient outcomes in the oncology domain.

FDA Approval

FDA Approval Drugs Sales Development

Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S.

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. Currently, 1 in 11 generic prescriptions dispensed in the U.S. Source link: [link].

Doctors

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Teva Announces Launch of a First Generic Version of Revlimid® (lenalidomide capsules), in the U.S.

The Pharma Data

MARCH 7, 2022

“The launch of our first generic version of Revlimid® in the U.S. This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”. Currently, 1 in 12 generic prescriptions dispensed in the U.S.

Medicine

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Hitting Pause on Criticism of the FDA, Just for Today

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. billion, about 50% was dedicated to regulating medical products, including prescription drugs. There are 19,000 approved prescription drugs for marketing in the U.S.

Generic Drugs

Generic Drugs Manufacturing Regulation Drugs

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

We delve into the driving forces behind their successes and shed light on the groundbreaking research that has earned them a place among the elite in the pharmaceutical arena. is a global pharmaceutical company, working across both developed and emerging markets. The FDA approved the drug over a decade ago in September 2009.

Sales

Sales Manufacturing FDA Approval Life Science

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

DECEMBER 12, 2019

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. The European Union (EU) has similar challenges to us when it comes to drug safety, including inspections of the plants that make pharmaceuticals for the European market.

Drugs

Drugs Manufacturing Medicine Compliance

Pathbreakers: The journey of first generics

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. from 2001 to 2022.”

Generic Drugs

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and.

Vaccination

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Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

Marketing

Marketing Pharmacy Production Branding

FDA proposes new model for easy-to-understand prescription guides

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The agency also aims to prevent misinformation and disinformation with this clearer form of patient communication.

Drugs

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Clinical Research Informer

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

Trending Sources

Drug labeling authority, UDI program reviewed by Harvard-based researchers

The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Expanding ketamine’s horizons to treat rare neurological disorders

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Top 40 Best-Selling Oncology Drugs in 2023 by 2022 Data

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

Top 40 Best-Selling Cancer Drugs in 2023 by 2022 Data

Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S.

Teva Announces Launch of a First Generic Version of Revlimid® (lenalidomide capsules), in the U.S.

Hitting Pause on Criticism of the FDA, Just for Today

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pathbreakers: The journey of first generics

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Humira biosimilars set the stage for long-awaited 2023 US launches

FDA proposes new model for easy-to-understand prescription guides

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