Promius files NDA for modified release tetracycline DFD-09

Promius Pharma, a subsidiary of Dr. Reddy’s Laboratory has filed a New Drug Application for a modified release tetracycline for the treatment of rosacea. Promius is calling their new drug DFD-09.

Promius Pharma is probably best know to rosacea sufferers via the availability of Promiseb Topical Cream in the US. Promiseb, a treatment for seborrheic dermatitis, is noteworthy as it prescription only but has no active ingredients.

Press Release

Dr. Reddy’s Laboratories and its subsidiary Promius Pharma announce the filing of three NDAs with the USFDA

Hyderabad, India and Princeton, USA . April 7, 2015

Dr. Reddy’s Laboratories (NYSE:RDY) and its subsidiary, Promius Pharma, LLC today announced the filing of three 505(b)(2) New Drug Applications (NDAs) with the U.S. Food and Drug Administration (US FDA).

The three NDAs – DFD-01, DFD-09, and DFN-11, are in support of Dr. Reddy’s Proprietary Products group, focused on developing and commercializing therapies in dermatology and neurology.

DFD-01 and DFD-09 are the first dermatology applications submitted to the NDA that have been fully developed leveraging in-house capabilities.

  • DFD-01 is a corticosteroid delivered in a novel non-irritating spray platform, intended for the treatment of patients suffering from psoriasis.
  • DFD-09 is a modified release oral tetracycline intended for the treatment of rosacea.

….

A Springer publication called Adis Insight tells us the that the mechanism of action of DFD-09 is “Protein 30S ribosomal subunit inhibitors”.

This is potentially good news for rosacea sufferers, especially if DFD-09 turns into a cheaper competitor to the expensive doxycycline-based treatment Oracea.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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