Drug Competition Action Plan

FDA: Record Number of Generic Drug Approvals

Abbreviated New Drug Applications (ANDAs), Approvals, Drug Competition Action Plan, FDA, FDA/Regulatory, Generic Drug User Fee Amendments, Generics, Tentative Approvals, Yale University

The U.S. Food and Drug Administration reported 1,171 generic drug approvals (935 full approvals and 236 tentative approvals) for fiscal year 2019, up from the previous all-time record total of 971 during 2018.

October 17, 2019/by BioSpace

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

Abbreviated New Drug Applications (ANDAs), Commissioner, Competitive Generic Therapies, Department of Health and Human Services (HHS), Draft Guidance, Drug Competition Action Plan, FDA/Regulatory, Generics

“We have been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development,” says FDA Commissioner Scott Gottlieb, M.D.

February 15, 2019/by Administrator

FDA approves Amneal’s generic dementia patch

Alzheimer’s Disease, Approvals, Biologics, Biosimilars, Department of Health and Human Services (HHS), Drug Competition Action Plan, FDA, FDA/Regulatory, Generics, J.P. Morgan Healthcare Conference, Market Value, Parkinson’s disease, Patches, Patent Litigation, Product Pipelines, Transdermal Patches

The U.S. FDA approved Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases.

January 14, 2019/by BioSpace

FDA Proposes Steps to Standardize Generic Drugs Globally

Biologics, Biosimilars, Donald Trump, Drug Competition Action Plan, European Medicines Agency (EMA), FDA, FDA/Regulatory, Generics, Pricing, Therapeutics

U.S. Food and Drug Administration Commissioner Scott Gottlieb announced that the regulatory agency is relaunching the Drug Competition Action Plan in 2019 with some additional initiatives.

October 19, 2018/by BioSpace

As Congress struggles with healthcare reform, Gottlieb’s FDA is taking action

Apps, August 2017, Commissioner, Congress, Digital Health, Digital Health Innovation Plan, Drug Competition Action Plan, FDA/Regulatory, Generics, John Kamp, Obamacare/Affordable Care Act (ACA), Opioids, Wall Street, White House

While the nation’s media was focusing on the unsuccessful attempts by Republicans to pass a successor to Obamacare, a fascinating sideshow has developed in nearby White Oak, Maryland, home of the Food and Drug Administration.

August 1, 2017/by John Kamp

FDA Tackles Drug Competition

Abbreviated New Drug Applications (ANDAs), Branded Generics, Drug Competition Action Plan, Expirations, FDA, FDA/Regulatory, Generic Drug Applications, Generics, Patents, Prescription Drugs

The U.S. FDA is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.

June 27, 2017/by PR Newswire