May 25, 2017
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"The US Food and Drug Administration (FDA) has approved two new dermal fillers to improve the appearance of nasolabial fold (NLF) wrinkles in adults, the manufacturer Galderma has announced.

Restylane Refyne was approved for "...



(azficel-T) for Intradermal Injection Only


LAVIV is an autologous cellular product composed of fibroblasts suspended in Dulbecco's Modified Eagle's Medium (DMEM) without phenol red. Dermal fibroblasts from post-auricular skin biopsy tissue are aseptically expanded using standard tissue-culture procedures until sufficient cells for three doses are obtained. Cells are then cryopreserved in a protein-free solution containing DMSO. When the patient administration is scheduled, cells are thawed, washed, and shipped to the clinic. A final sterility test is initiated prior to shipping, but the result will not be available for up to 14 days. A passing sterility culture result from the test performed on the cryopreserved bulk material (Drug Substance) and a negative Gram stain test result on the final LAVIV drug product are required for release of a product for shipping.

Last reviewed on RxList: 5/27/2016
This monograph has been modified to include the generic and brand name in many instances.

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