FDA Issues Product-Specific Guidance Documents for Chloroquine Phosphate and Hydroxychloroquine Sulfate

April 15, 2020

On Tuesday, April 14th, FDA released two product-specific guidance documents for chloroquine phosphate tablets and hydroxychloroquine sulfate tablets, two drugs being investigated as potential treatments for COVID-19.  These guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).

The guidance, entitled Guidance on Hydroxychloroquine Sulfate was developed using the process described in that guidance and finalizes the draft guidance of the same title issued in April 2011. The guidance entitled Guidance on Chloroquine Phosphate is being implemented without prior public comment because FDA has determined that prior participation for this guidance is not feasible or appropriate in light of the coronavirus disease 2019 (COVID-19) public health emergency.

The guidance on Chloroquine Phosphate does not require an in-vivo demonstration of bioequivalence and only requires that the in-vitro dissolution profiles of the proposed products are comparable to those of the reference products.  The reference standard products are the chloroquine phosphate tablets manufactured by Natco Pharma Limited approved under ANDA 091621.

The guidance on Hydroxychloroquine Sulfate provides two options for demonstrating bioequivalence. Option one is to use the Biopharmaceutics Classification System (BCS)-based biowaiver; and option two is the more common in-vivo fed and fasting bioequivalence studies but measuring the hydroxychloroquine analyte in whole blood.  The reference standard product is Plaquenil® tablet manufactured by CONCORDIA PHARMACEUTICALS INC approved under NDA 009768.

Are you in the process of developing a branded or generic drug?  Regardless of the type of FDA-regulated product, we can help you achieve successful interactions with the FDA.  To learn more about our services and how we can help you, contact us today.



Agency Alerts General Regulatory

April 15, 2016

FDA Gains Ground in Development of Pilot Program Required Under Drug Supply Chain Security Act

The Drug Supply Chain Security Act (DSCSA), which was signed into law in November 2013, “outlines critical steps to build an electronic, interoperable system” to identify and trace prescription drugs...

Read the Full Article
Agency Alerts Ophthalmic

March 22, 2022

FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance with 21 CFR Part 4

The U.S. Food and Drug Administration today issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. This guidance provides information to...

Read the Full Article
Agency Alerts General Regulatory

September 22, 2015

FDA to Change Long Standing Practice of Not Posting Individuals’ Comments Publicly

In the past, FDA has made a point that comments posted by individuals (in an individual capacity and not on behalf of an organization, corporation, or other entity) are not posted publicly. This is a...

Read the Full Article