Type 2 Diabetes Mellitus

• FDA approval · 2019-08-12
  FDA Tentative Approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  FDA issued tentative approval for a generic fixed-dose combination of dapagliflozin and metformin hydrochloride, manufactured by Prasco Labo…

• FDA approval · 2019-08-08
  FDA Approved: XULTOPHY 100/3.6 — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for XULTOPHY 100/3.6, a fixed-ratio combination of insulin degludec and liraglutide, from Novo N…

• FDA approval · 2019-07-22
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Metformin Hydrochloride from Sun Pharmaceutical Industries, Inc., validating a generic metfo…

• FDA approval · 2019-07-03
  FDA Approved: TRADJENTA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TRADJENTA (linagliptin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2019-07-03
  FDA Approved: JENTADUETO — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for JENTADUETO (linagliptin and metformin hydrochloride) from Boehringer Ingelheim Pharmaceuticals, …

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• FDA approval · 2019-07-03
  FDA Approved: JENTADUETO XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for JENTADUETO XR (linagliptin and metformin hydrochloride) by Boehringer Ingelheim Pharmaceutic…

• FDA approval · 2019-07-01
  FDA Approved: ALOGLIPTIN AND PIOGLITAZONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application from Padagis Israel Pharmaceuticals Ltd for a fixed-dose combination tablet of alogliptin benzoa…

• FDA approval · 2019-07-01
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for JANUMET (sitagliptin and metformin hydrochloride) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2019-07-01
  FDA Approved: JANUMET XR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for JANUMET XR (sitagliptin and metformin hydrochloride) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2019-07-01
  FDA Approved: ALOGLIPTIN — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for alogliptin, a diabetes medication, submitted by Padagis Israel Pharmaceuticals Ltd, reflecting c…

• FDA approval · 2019-07-01
  FDA Approved: GLYXAMBI — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for GLYXAMBI (empagliflozin and linagliptin) from Boehringer Ingelheim Pharmaceuticals, Inc. The…

• FDA approval · 2019-07-01
  FDA Approved: STEGLUJAN — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for STEGLUJAN, a fixed-dose combination of ertugliflozin and sitagliptin, developed by Merck Sharp &…

• FDA approval · 2019-07-01
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for JANUVIA (sitagliptin) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2019-07-01
  FDA Approved: TRADJENTA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TRADJENTA (linagliptin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2019-07-01
  FDA Approved: KAZANO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for KAZANO, a fixed-dose combination of alogliptin and metformin hydrochloride, by Takeda Pharma…

• FDA approval · 2019-07-01
  FDA Approved: JENTADUETO XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for JENTADUETO XR (linagliptin and metformin hydrochloride) submitted by Boehringer Ingelheim Ph…

• FDA approval · 2019-07-01
  FDA Approved: JENTADUETO — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for JENTADUETO (linagliptin and metformin hydrochloride) submitted by Boehringer Ingelheim Pharmaceu…

• FDA approval · 2019-06-20
  FDA Approved: MYXREDLIN — Original Application (Baxter Healthcare Corporation)

  FDA approved MYXREDLIN (insulin human) from Baxter Healthcare Corporation through an original application for use in the treatment of diabet…

• FDA approval · 2019-05-31
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Accord Healthcare Inc)

  The FDA approved a supplemental application for glimepiride by Accord Healthcare Inc, authorizing changes to the approved product.

• FDA approval · 2019-05-31
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for glimepiride from Carlsbad Technology, Inc., granting approval to market a generic form of the di…

• FDA approval · 2019-05-31
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for glimepiride from Dr. Reddy's Laboratories Limited. Glimepiride is a generic drug used to treat t…

• FDA approval · 2019-05-31
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Glimepiride from Rising Pharma Holdings, Inc., signaling regulatory clearance for a change t…

• FDA approval · 2019-05-21
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., resulting in changes to …

• FDA approval · 2019-05-21
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA has approved Cosette Pharmaceuticals' supplemental application for Welchol (colesevelam hydrochloride). This action constitutes an a…

• FDA approval · 2019-05-09
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for LANTUS SOLOSTAR (insulin glargine) from Sanofi-aventis U.S. LLC.