Heart Failure

• FDA approval · 2018-01-26
  FDA Approved: KAPSPARGO — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved KAPSPARGO (metoprolol succinate) through an original new drug application by Sun Pharmaceutical Industries, marking regulatory …

• FDA approval · 2018-01-23
  FDA Approved: BUMETANIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Bumetanide under an Original Application for Upsher-Smith Laboratories, establishing a generic version of the loop diuretic.

• FDA approval · 2017-10-25
  FDA Approved: CARVEDILOL PHOSPHATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved an original-application generic product of carvedilol phosphate from Sun Pharmaceutical Industries.

• FDA approval · 2017-10-18
  FDA Approved: BUMETANIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's original application for bumetanide, granting approval of a generic bumetanide product.

• FDA approval · 2017-09-22
  FDA Approved: INDAPAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Indapamide (ANI Pharmaceuticals), updating its regulatory approval.

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• FDA approval · 2017-07-21
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for ZESTRIL (lisinopril) submitted by Upsher-Smith Laboratories.

• FDA approval · 2017-07-19
  FDA Approved: CANDESARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for candesartan from Macleods Pharmaceuticals Limited, enabling a generic version of the drug.

• FDA approval · 2017-07-14
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc. The notice confirms regulatory approval o…

• FDA approval · 2017-06-20
  FDA Approved: CANDESARTAN CILEXETIL — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original application for candesartan cilexetil, enabling the marketing of a generic candesartan cilexe…

• FDA approval · 2017-05-26
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Radha Pharmaceuticals, Inc.)

  FDA approved a generic version of hydralazine hydrochloride under an Original Application for the treatment of hypertension.

• FDA approval · 2017-03-30
  FDA Approved: CHLORTHALIDONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved an original application for chlorthalidone from Rising Pharma Holdings, Inc., a generic diuretic indicated for hypertension and…

• FDA approval · 2017-03-08
  FDA Approved: NIPRIDE RTU — Original Application (EXELA PHARMA SCIENCES, LLC)

  FDA approved Nipride RTU (sodium nitroprusside) from Exela Pharma Sciences as an original NDA. The product provides a ready-to-use formulati…

• FDA approval · 2017-03-01
  FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Farxiga (dapagliflozin) from AstraZeneca Pharmaceuticals LP. This action updates the drug's …

• FDA approval · 2016-12-01
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Advanz Pharma US Corp.

• FDA approval · 2016-12-01
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Digoxin from Hikma Pharmaceuticals USA Inc. The action reflects approved product changes und…

• FDA approval · 2016-11-25
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for metoprolol succinate, establishing a generic sustained-release formulation from Actavis Pharma, In…

• FDA approval · 2016-10-27
  FDA Approved: ACETAZOLAMIDE — Original Application (Chartwell RX, LLC)

  FDA approved an original application for acetazolamide from Chartwell RX, LLC.

• FDA approval · 2016-10-07
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for furosemide submitted by Marlex Pharmaceuticals, Inc.

• FDA approval · 2016-09-22
  FDA Approved: FUROSEMIDE — Supplemental Application (Hospira, Inc.)

  FDA approves Hospira, Inc.'s supplemental application for furosemide, initiating a supplemental approval for the drug. The action updates th…

• FDA approval · 2016-09-19
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2016-09-19
  FDA Approved: SPIRONOLACTONE — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare, Inc.'s original application for spironolactone (generic), authorizing its use as a potassium-sparing diureti…

• FDA approval · 2016-09-16
  FDA Approved: VALSARTAN — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved the original ANDA for valsartan from Macleods Pharmaceuticals Limited, making a generic ARB option available. This approval…

• FDA approval · 2016-09-15
  FDA Approved: QUINAPRIL — Original Application (Solco Healthcare US, LLC)

  FDA approves the original application for Quinapril, granting approval for a generic version manufactured by Solco Healthcare US, LLC.

• FDA approval · 2016-09-13
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for lisinopril submitted by Aurobindo Pharma Limited under ANDA 077622.

• FDA approval · 2016-09-08
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC under an ANDA, confirming the approval of this ge…