Welcome to HeteroGeneity, LLC.
HeteroGeneity, LLC is a specialty consulting firm providing strategic and technical advice, and hands-on assistance to product sponsors interested in the development and policy of ingredients and products targeted for the United States market.
Our focus is on complex products, such as botanicals, fish oils, biologics and other products of natural or complex composition.
We work with sponsors to address difficult and often novel FDA regulatory issues.
National Cancer Institute's Office of Cancer Complementary and Alternative Medcine holds a workshop on the development of botanical drugs:
"......Conducting a successful Phase III clinical trial is a critical research benchmark for any new cancer treatment. Reaching that goal is daunting for all potential therapies, but it is especially so for botanical compounds...."
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US FDA Approves 2nd Botanical Drug
The United States Food and Drug Administration (FDA) in an agency press release on December 31, 2012, announced its approval of Fulyzaq™ (125 mg tablets) (Crofelemer) [Salix Pharmaceuticals, Ltd. Raleigh, North Carolina: (NASDAQ:SLXP)] ("Salix") for HIV-associated diarrhea. Crofelemer, which is a proprietary extract from the red sap of the South American croton tree Croton lechleri Muell. Arg., is the second botanical drug to be approved under a New Drug Application (NDA) for marketing in the United States. It is the first NDA-approved botanical drug for oral administration, and the first for the clinical indication. FDA approved the first new botanical drug, Veregen® (Polyphenon® E) ointment (15%) [MediGene AG, Planegg/Martinsreid - Germany] in 2006 for the topical treatment of genital warts. Veregen is a proprietary extract from green tea leaves (Camellia sinensis [L.] O Kuntze).
To be approved, both products must have met all of the US requirements for pharmaceuticals. Both can only be dispensed by prescription. Both are naturally complex (polymolecular) products.
To date the FDA has received >500 Investigational New Drug applications and preINDs for botanical drugs, and two NDAs have been submitted to FDA and two have now been approved.