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27-Sep-2018

FDA Grants Profounda Inc. Competitive Generic Therapy (CGT) Designation for planned ANDA filing of Minocycline Hydrochloride Microspheres,1 mg

FDA Grants Profounda Inc. Competitive Generic Therapy (CGT) Designation for planned ANDA filing of Minocycline Hydrochloride Microspheres,1 mg - Applicants for drugs with a CGT designation may receive enhanced and expedited review processes of their ANDA. - FDA determined that the drug product under Profounda's planned ANDA meets the criteria for designation as a CGT pursuant to section 506H(b) of the FD&C Act.

PR Newswire

ORLANDO, Fla., Sept. 27, 2018

ORLANDO, Fla., Sept. 27, 2018 /PRNewswire/ -- Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's Competitive Generic Therapy (CGT) Designation for the planned future ANDA filing of Minocycline Hydrochloride Microspheres, 1 mg, pursuant to section 506H(b) of the FD&C Act.

The CGT program came into being following the FDA Reauthorization Act 2017 (FDARA) and is designed to reduce the number of review cycles that generic applications usually undergo. A drug can qualify for CGT designation if there is no more than 1 approved drug in the active section of the FDA's Orange Book. The first approvals under this act were granted in August of 2018.  Brand sales for this drug exceed $150 Million USD and represent an exciting generic opportunity for the company. If approved, patients needing treatment for periodontal disease may have an effective and more affordable generic alternative for treatment.

About Profounda, Inc.

Profounda is a product-oriented, privately backed pharmaceutical company that aims to license or develop high quality specialty niche pharmaceutical products in both the branded and generic pharmaceutical markets. Our objectives are to bring high quality, innovative options to patients being treated for various conditions, and to improve the lives of those that take our medication. Profounda's commercial products include Impavido® for Leishmaniasis and Rhinase® Nasal Gel and Rhinase® Nasal Mist to help patients with nasal dryness.  For more information, visit Profounda's website at www.profounda.com or the product websites at Impavido.com and Rhinase.com

Contact: Leah MacLaughlan, 407-270-7790, leahm@profounda.com

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SOURCE Profounda, Inc.

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Last Updated: 27-Sep-2018