Abbreviated New Drug Applications (ANDAs) Archives

Blue Cross and Civica Rx Form New Company to Develop Generic Drugs

Abbreviated New Drug Applications (ANDAs), Blue Cross Blue Shield, Business, California, Generics, New Subsidiaries

Civica Rx and 18 independent Blue Cross and Blue Shield (BCBS) companies formed a new subsidiary dedicated to lowering the cost of select generic drugs.

January 23, 2020/by BioSpace

FDA to Pull Nearly 250 ANDAs

Abbreviated New Drug Applications (ANDAs), FDA, FDA/Regulatory, Generics

The U.S. Food and Drug Administration intends to pull nearly 250 Abbreviated New Drug Applications (ANDAs) following the failure of manufacturers to submit annual reports.

January 10, 2020/by BioSpace

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Drug Applications (ANDAs), Commissioner, Competitive Generic Therapies, Department of Health and Human Services (HHS), Draft Guidance, Drug Competition Action Plan, FDA/Regulatory, Generics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

Aurobindo Receives FDA Approval for Dalfampridine Extended-Release Tablets, 10 mg

Abbreviated New Drug Applications (ANDAs), Approvals, FDA, FDA/Regulatory, Generics, IMS Health, Multiple Sclerosis

The U.S. FDA granted final approval to Aurobindo Pharma Limited’s generic treatment for multiple sclerosis.

January 25, 2017/by Administrator

Aurobindo Receives FDA Approval for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg

Abbreviated New Drug Applications (ANDAs), Alzheimer's, Alzheimer's Diseases, ANDAs, FDA, FDA/Regulatory, Generics

Dayton, N.J., October 22, 2015 – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg. […]

October 22, 2015/by Administrator