Branding, FDA Approval, Generic Drugs and Pharmacy

Faster FDA Approvals Don’t Affect Generic Drug Availability or Cost

Pharmacy Checkers

JULY 11, 2019

I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.” generic for 3 of the drugs.

Generic Drugs

Generic Drugs FDA Approval Drugs Branding

When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Pharmacy Checkers

FEBRUARY 14, 2020

Joe and Teresa Graedon, founders of The People’s Pharmacy , not only have an admirable track record of telling health consumers how it is, but also listening to those in their readership. Many readers complained that it just wasn’t cutting it compared to the brand name version. Just switch back to the brand!”

Branding

Branding FDA Approval Pharmacy Bioequivalency

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.

Insulin

Insulin Production FDA Approval Generic Drugs

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. He went to our site to discover that brand-name Livalo ( pitavastatin ). pharmacies.

FDA Approval

FDA Approval Branding Pharmacy Manufacturing

Valisure Supports Drug Importation

Pharmacy Checkers

SEPTEMBER 10, 2020

online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. When people go online or to their local Walgreens to buy prescription drugs domestically, they are largely relying on the regulatory strength of the U.S.

Drugs

Drugs FDA Approval Generic Drugs Branding

FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Pharmacy Checkers

OCTOBER 11, 2019

It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. Its indirect relation to personal drug importation is noted at the end of this post. This is surprising.

FDA Approval

FDA Approval Drugs Manufacturing Pharmacy

Maine and Nevada Update Drug Price Transparency Laws

FDA Law Blog

JULY 22, 2021

LD 686 also revises the process for disclosures by manufacturers, wholesale drug distributors and pharmacy benefits managers (PBMs). Previously, manufacturers, wholesale drug distributors and PBMs were required to provide “pricing component data” within 60 days of a request from the state.

Drugs

Drugs Manufacturing Generic Drugs FDA Approval

Hitting Pause on Criticism of the FDA, Just for Today

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.

Generic Drugs

Generic Drugs Manufacturing Regulation Drugs

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

MARCH 11, 2020

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts. Part J is written in three sections.

Pharmacy

Pharmacy Drugs FDA Approval Licensing

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

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. e), the Agency will approve or deny the petition no later than 90 days after the petition is submitted.”

Generic Drugs

Generic Drugs Drugs Branding Production

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

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. e), the Agency will approve or deny the petition no later than 90 days after the petition is submitted.”

Generic Drugs

Generic Drugs Drugs Branding Production

Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

Pharmacy Checkers

JANUARY 30, 2020

Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug. Basically, the charge is that the Vyera took myriad actions to prevent a lower-cost generic drug from coming to market.

Drugs

Drugs Generic Drugs Cosmetics FDA Approval

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

Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. When it comes to the approval of new drugs, brand and generic, the systems of the U.S.

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.

Generic Drugs

Generic Drugs Branding Drugs Production

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

Pharmaceutical Technology

DECEMBER 4, 2022

While small molecule drugs can be remade into identical generics, biologics are more complex. There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Watanabe says there are going to be some attempts by an innovator brand to defend its space.

Marketing

Marketing Pharmacy Production Branding

Exforge antitrust settlement caps Novartis’ year of legal disputes

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.”. Novartis $245 million settlement. Gilenya legal drama.

Doctors

Doctors Doctor Drugs Sales

Clinical Research Informer

Faster FDA Approvals Don’t Affect Generic Drug Availability or Cost

When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Trending Sources

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

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

Valisure Supports Drug Importation

FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Maine and Nevada Update Drug Price Transparency Laws

Hitting Pause on Criticism of the FDA, Just for Today

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

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”)

Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

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

Pathbreakers: The journey of first generics

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

Exforge antitrust settlement caps Novartis’ year of legal disputes

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