USFDA gives approval for Doxycycline Hyclate delayed-release Tablets

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

Lupin Limited, a global pharmaceutical giant, recently announced that it has gained approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for doxycycline hyclate delayed-release tablets USP.

This approval is for doxycycline hyclate delayed-release tablets USP, with strengths ranging from 50 mg to 200 mg.

These tablets will serve as a generic alternative to Doryx delayed-release tablets, which come in strengths of 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg.

Additionally, they will also be a generic equivalent to Doryx MPC delayed-release tablets with strengths of 60 mg and 120 mg.

The original Doryx products were developed by Mayne Pharma International Pty. Ltd.

Lupin will produce this new generic product at its Pithampur facility, located in India.

Doryx, also known as doxycycline hyclate delayed-release tablets USP, is a medication commonly used for various medical conditions.

Lupin’s approval from the USFDA paves the way for them to offer a more affordable generic version of Doryx tablets to the market.

This will provide patients with an alternative treatment option that can be more cost-effective while maintaining the same essential properties as the brand-name product.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.

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