Atrial Flutter

• FDA approval · 2022-12-02
  FDA Approved: ESMOLOL HYDROCHLORIDE — Original Application (WG Critical Care, LLC)

  FDA approved the original application for esmolol hydrochloride in saline (sodium chloride) solution, a generic injectable beta-blocker.

• FDA approval · 2022-11-28
  FDA Approved: DOFETILIDE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for dofetilide filed by Bionpharma Inc. under an ANDA, approving a change to the approved product.

• FDA approval · 2022-10-25
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for sotalol hydrochloride by Teva Pharmaceuticals USA, Inc., indicating regulatory approval of a…

• FDA approval · 2022-09-23
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (ScieGen Pharmaceuticals, Inc)

  FDA approves ScieGen's generic diltiazem hydrochloride under an Original Application (ANDA).

• FDA approval · 2022-09-08
  FDA Approved: FLECAINIDE ACETATE — Original Application (Epic Pharma, LLC)

  FDA approved the original application for flecainide acetate tablets from Epic Pharma, LLC under ANDA215599.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2022-08-08
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved Slate Run Pharmaceuticals' generic diltiazem hydrochloride under an original ANDA.

• FDA approval · 2022-06-15
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA approves a generic Verapamil Hydrochloride product from Lifestar Pharma LLC under an Original Application (ANDA).

• FDA approval · 2022-05-05
  FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE — Original Application (Dr. Reddy's Labratories Inc.)

  FDA approves Dr. Reddy's Laboratories' generic diltiazem hydrochloride extended-release tablet (ANDA 215775).

• CLINICAL_TRIALS trial_result · 2022-04-08
  Clinical Trial Update: Start or STop Anticoagulants Randomised Trial (SoSTART) [Phase 3]

  A Phase 3 trial evaluating start or stop anticoagulants in patients with various intracranial hemorrhage contexts and atrial fibrillation/fl…

• FDA approval · 2022-03-21
  FDA Approved: ESMOLOL HYDROCHLORIDE — Original Application (Eugia US LLC)

  FDA approved the original application for esmolol hydrochloride in sodium chloride injection, a generic product manufactured by Eugia US LLC…

• FDA approval · 2022-03-17
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original Abbreviated New Drug Application for verapamil hydrochloride from Heritage Pharmaceuticals (d/b/a Avet) as a gener…

• FDA approval · 2022-03-11
  FDA Approved: DIGOXIN — Original Application (Amici Pharma, Inc)

  FDA approved the original ANDA for digoxin from Amici Pharma, authorizing a generic digoxin product.

• FDA approval · 2022-02-08
  FDA Approved: DIGOXIN — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic digoxin product, enabling marketing in the United States.

• FDA approval · 2021-12-20
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  The FDA approved a supplemental application for Hospira's verapamil hydrochloride under an existing approved product, marking an update to t…

• FDA approval · 2021-11-22
  FDA Approved: DIGOXIN — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' generic digoxin product (DIGOXIN) under an original ANDA. Digoxin is used to treat heart failure and certa…

• FDA approval · 2021-10-14
  FDA Approved: DOFETILIDE 0.125MG — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved a generic version of dofetilide (0.125 mg) from Granules Pharmaceuticals Inc., expanding access to this antiarrhythmic.

• FDA approval · 2021-06-03
  FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)

  FDA approved a supplemental application for Betapace (sotalol hydrochloride) filed by Legacy Pharma USA, Inc.

• FDA approval · 2021-04-21
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approves Zydus Lifesciences Limited's original application for propafenone hydrochloride (generic). The approval covers the treatment of…

• FDA approval · 2021-03-22
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approves Glenmark's diltiazem hydrochloride as an original ANDA; the product is a generic calcium channel blocker indicated for hyperten…

• FDA approval · 2021-03-02
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride by Mylan Pharmaceuticals, signaling approval of an updated or additional…

• FDA approval · 2021-02-04
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for sotalol hydrochloride by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2021-02-04
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved AiPing Pharmaceutical, Inc.'s supplemental application for Sotalol Hydrochloride.

• FDA approval · 2021-01-27
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Sotalol Hydrochloride from Apotex Corp., approving changes to this generic product.

• FDA approval · 2020-11-30
  FDA Approved: DOFETILIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application from Aurobindo Pharma Limited to manufacture and market dofetilide as a generic drug.

• FDA approval · 2020-11-16
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a supplemental application for Multaq (dronedarone) submitted by Sanofi-Aventis U.S. LLC.