Indication:
Proprietary Name- KYBELLA
Established Name- Deoxycholic Acid
Applicant- Kythera Biopharmaceuticals INC
Indication- For Improvement in the appearance of Moderate to Severe
of Convexity or Fullness associated with Submetal Fat in Adults
Approval Date- 4/29/2015
Approved by U.S.FDA on 30-06-2015 (Ref- FDA approved List- 2015)
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.12
Drug Name - Deoxycholic acid
Active Ingredient- Kybella
Date of approval - 4/29/2015
FDA-approved use - To treat adults with moderate-to-severe fat
below the chin, known as submental fat
Approved by US FDA on 4/29/2015- (Ref- FDA approved List- 2015)
Manufacturer Details