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Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke Kit for the Treatment of Severe Hypoglycemia drugs
August 25, 2021
Xeris today announced that its supplemental new drug application (sNDA) of Gvoke® Kit was approved by the Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.
FDA Accepts sNDA with Priority Review for FETROJA americanpharmaceuticalreview
June 11, 2020
Shionogi announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation ...
FDA approves sNDA for candidiasis treatment in paediatric patients europeanpharmaceuticalreview
January 13, 2020
Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.
Ocular Therapeutix Announces FDA Approval of Dextenza (dexamethasone intracanalicular insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery drugs
June 25, 2019
Ocular Therapeutix Announces FDA Approval of Dextenza (dexamethasone intracanalicular insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery.
J&J submits sNDA for Invokana after premature end to clinical trial pharmatimes
April 02, 2019
Johnson & Johnson’s Janssen has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a new indication for Invokana (canagliflozin).
KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP) drugs
January 08, 2019
KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA) has approved a......
Horizon Pharma Announces FDA Approval to Expand Age Range for RAVICTI americanpharmaceuticalreview
December 29, 2018
Horizon Pharma announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for....
Janssen Submits sNDA for Xarelto to Prevent VTE in Acute Medically Ill Patients americanpharmaceuticalreview
December 17, 2018
Janssen Pharmaceutical announced the submission of a supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) to the U.S. Food and Drug Administration (FDA) for the prevention of......
Janssen Submits sNDA for Xarelto to Prevent VTE in Acute Medically Ill Patients americanpharmaceuticalreview
December 17, 2018
Janssen Pharmaceutical announced the submission of a supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) to the U.S. Food and Drug Administration (FDA) for the prevention of......
Allergan Announces FDA Acceptance of sNDA for AVYCAZ americanpharmaceuticalreview
November 29, 2018
Allergan announced the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam)

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