Smoking Cessation

• CLINICAL_TRIALS trial_result · 2008-10-10
  Clinical Trial Update: Combination Medications vs. Patch Alone for Medically-Ill Smokers [Phase 4]

  Phase 4 trial comparing combination medications versus nicotine patch alone for smoking cessation in medically ill smokers has completed. Th…

• FDA approval · 2008-07-09
  FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Bupropion Hydrochloride XL, resulting in modifications to labeling/indications for the product.

• FDA approval · 2008-05-16
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Chantix (varenicline tartrate) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2008-04-14
  FDA Approved: FOSTER AND THRIVE NICOTINE — Supplemental Application (Strategic Sourcing Services LLC)

  FDA approved a supplemental application for Foster and Thrive Nicotine (nicotine polacrilex), a nicotine replacement therapy, submitted by S…

• FDA approval · 2008-01-31
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Chantix (varenicline tartrate) submitted by Pfizer Laboratories Div Pfizer Inc.

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• FDA approval · 2007-11-20
  FDA Approved: CHANTIX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for CHANTIX (varenicline tartrate) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2007-09-17
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal's supplemental ANDA for generic bupropion hydrochloride, enabling marketing of a generic formulation.

• FDA approval · 2007-06-26
  FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) filed by Haleon US Holdings LLC.

• FDA approval · 2007-06-26
  FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)

  FDA approved a supplemental application for NICORETTE 4MG FRUIT CHILL GUM (nicotine polacrylex) from Lil' Drug Store Products, expanding the…

• FDA approval · 2007-06-04
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Epic Pharma LLC)

  FDA approved a supplemental application for Bupropion Hydrochloride from Epic Pharma LLC, granting regulatory approval of this generic produ…

• FDA approval · 2007-04-13
  FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Sam's West Inc)

  FDA approved a supplemental application for the Nicotine Transdermal System submitted by Sam's West Inc.

• FDA approval · 2007-03-08
  FDA Approved: RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR — Supplemental Application (Rugby Laboratories)

  FDA approved a supplemental application for Rugby Nicotine Polacrilex Gum, Original Flavor, expanding its labeling for this nicotine replace…

• FDA approval · 2006-09-15
  FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Sam's West Inc)

  FDA approved a supplemental application for the nicotine transdermal system (nicotine patch) filed by Sam's West Inc, updating the product's…

• FDA approval · 2006-05-05
  FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Dr. Reddys Laboratories Inc.)

  FDA approved a supplemental application for the Nicotine Transdermal System (nicotine patch) from Dr. Reddys Laboratories Inc., maintaining/…

• FDA approval · 2006-05-04
  FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)

  FDA approved a supplemental application for NICORETTE 4MG FRUIT CHILL GUM by Lil' Drug Store Products, Inc., enabling market authorization o…