HealthLeaders Media

FDA Launches Streamlined Generic Drug Approval Process

The Competitive Generic Therapy designation looks to encourage the development of alternatives for drugs with inadequate generic competition. The Food and Drug Administration on Wednesday approved a ...
The American Journal of Managed Care

FDA Approves First Generic Under New Pathway for Boosting Drug Competition

The FDA has approved several strengths of potassium chloride oral solutions as the first generic drugs to receive a Competitive Generic Therapy designation. The FDA has approved the first generic drug ...
Wall Street Journal

Waxman Charts a Pathway for Generic Biotech Drugs

Two weeks ago, President Obama called for generic competition for some of the country's costliest drugs. Today, lawmakers joined the fight, proposing legislation that would pave the way for sales of ...
FiercePharma

FDA approves first generic under new pathway designed to fight drug price gouging

Even as the Trump Administration has grabbed headlines in recent months with efforts to control drug prices, another program at the FDA has yielded early results with a generic drug approval. The FDA ...
JD Supra

FDA Issues Competitive Generic Therapies (CGTs) Statement and Guidance Regarding CGT Designation, Approval Pathway, and Market Exclusivity

The FDA recently issued a draft guidance (the guidance) outlining various aspects of the Competitive Generics Therapy (CGT) approval pathway, designation, and market exclusivity. 10 The guidance ...
Monthly Prescribing Reference

FDA Approves First Drug Under the Competitive Generic Therapy Pathway

FDA LOGO BLUE Potassium chloride is an oral treatment indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary ...