Generics
Profounda Inc announces the US FDA's CGT Designation for ANDA filing of Minocycline Hydrochloride Microspheres in 1 mg
28 September 2018 -

Pharmaceutical company Profounda Inc stated on Thursday that it has passed the US Food and Drug Administration's Competitive Generic Therapy (CGT) Designation for the planned future ANDA filing of Minocycline Hydrochloride Microspheres in 1 mg under section 506H(b) of the FD&C Act.

Upon US FDA's approval, the patients needing treatment for periodontal disease may have an effective and more affordable generic alternative for treatment. The brand sales for Minocycline Hydrochloride Microspheres exceed USD150m and represent an exciting generic opportunity for the company.

According to the company, the applicants for drugs with a US FDA CGT designation may receive enhanced and expedited review processes of their ANDA.

The CGT programme followed the US FDA's Reauthorization Act 2017 (FDARA) 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 US FDA's Orange Book, concluded the company.

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