FDA Approval of sNDA for DEXTENZA for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for DEXTENZA to include the treatment of ocular inflammation... Read More
US FDA grants breakthrough therapy status to AbbVie’s venetoclax in combo with obinutuzumab for untreated adults patients with CLL
AbbVie announced that the US Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for use in... Read More
US FDA approves Supernus’ sNDA to expand Oxtellar XR label
Supernus Pharmaceuticals, Inc. announced that the United States Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA)... Read More
FDA Reject Pfizer’s Supplemental New Drug Application to Treat Psoriasis
U.S. health regulators have rejected Pfizer Inc.’s Xeljanz, or tofacitinib citrate supplemental new drug application to treat adult patients with moderate to... Read More
US FDA approves BioDelivery Sciences’ sNDA for manufacturing specification change for Bunavail
The US Food and Drug Administration (FDA) has approved BioDelivery Sciences International Inc’s Supplemental New Drug Application (sNDA) for a manufacturing specification... Read More
What is supplemental new drug application (snda)?
Application submitted for an already approved NDA (New Drug Application) for any changes in packaging, labelling, dosages, ingredients or new indications. A supplement is... Read More