FDA Approval, Generic Drugs, Marketing and Regulation

FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

Generic Drugs

Generic Drugs Manufacturing Drugs Cosmetics

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. It has however been contraindicated in people taking opioids.

FDA Approval

FDA Approval Marketing Branding Generic Drugs

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

FDA Approval

FDA Approval Production Drugs Generic Drugs

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

FDA Approval Generic Drugs Production Drugs

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

In the News: October Regulatory and Development Updates

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

Development

Development Bioequivalency Generic Drugs Production

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

Marketing FDA Approval Branding Production

FDA hands Cassiopea its first approval, for acne drug Winlevi

pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company. Cassiopea spun out of Ireland-domiciled Cosmo Pharma in 2015.

Dermatology

Dermatology Drugs Hormones FDA Approval

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. After all, it never invested the time and resources necessary to obtain approval for commercial marketing or use. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. Men in Black from the PTO’s PTE branch might have gotten to us. Lehman , No.

Marketing

Marketing Production FDA Approval Cosmetics

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

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

Drugs Research FDA Approval Manufacturing

Expanding ketamine’s horizons to treat rare neurological disorders

Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. The drug is also known for its illegal recreational use. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray.

Research

Research Trials Drugs Generic Drugs

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

XTalks

FEBRUARY 5, 2024

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. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5

FDA Approval

FDA Approval Drugs Sales Development

Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales ( STAT ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ).

Vaccination

Vaccination Vaccine Drugs Regulation

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. The FTC notes in its Press Release that FDA supports the FTC Policy Statement, but there’s no further discussion of FDA’s role here.

Drugs

Drugs Branding Drug Delivery Systems Generic Drugs

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

XTalks

FEBRUARY 5, 2024

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. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5

FDA Approval

FDA Approval Drugs Sales Development

It’s PANDA-monium at FDA

FDA Law Blog

AUGUST 16, 2021

Nonetheless, FDA has been calling them ANDAs and listing them in the Orange Book as ANDAs for years, but recent changes to the Orange Book have spurred some confusion. Thus, FDA divided them into their own category and is now seeking Comments on whether the 505(b) or the 505(j) regulatory scheme should apply.

Production

Production Drugs Cosmetics Generic Drugs

Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

Generic Drugs

Generic Drugs Manufacturing Regulation Drugs

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

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. 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

Testimony this week by the Government Accountability Office before the House Energy and Commerce Subcommittee on Oversight and Investigations about the FDA’s potential failures to protect the public health may not take you into such a totally lopsided universe, but it shows that things may not be so golden. What about other countries?

Drugs

Drugs Manufacturing Medicine Compliance

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. in December 2019; and.

Vaccination

Vaccination Vaccine Production Sales

Clinical Research Informer

FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

Trending Sources

FDA-Approved Labeling: Is Enough Enough?

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

In the News: October Regulatory and Development Updates

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

FDA hands Cassiopea its first approval, for acne drug Winlevi

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

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

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

Expanding ketamine’s horizons to treat rare neurological disorders

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

Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

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

It’s PANDA-monium at FDA

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?

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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