Generic Drugs

FDA Breaks Generic Drug Approval Record

October 21, 2019

The agency announced it has approved 1171 generic drugs in fiscal year 2019.

Getting in Touch with New Guidance on Topical Products

October 02, 2019

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Nephron, UofSC Researchers Collaborate on Automation

September 16, 2019

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.

Generics: Getting Beyond “File First, Figure it Out Later”

September 15, 2019

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

FDA Expands Scope of API Impurity Investigation

August 29, 2019

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

Generics: Getting Beyond “File First, Figure it Out Later”

August 20, 2019

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues

European Specialty Pharmaceutical Company Launches First Products in UK

July 31, 2019

Neuraxpharm Group has announced it is launching its first products in the United Kingdom.

FDA Releases Draft Guidance on Using the Inactive Ingredient Database

July 10, 2019

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

Guidance on the Harmonization of Compendial Standards Published

July 10, 2019

FDA released draft guidance on using the USP pending monograph process in the drug application process.

Macleods Issues Recall Due to NMBA Impurities

July 01, 2019

More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.