Parkinson Disease

• FDA approval · 2015-04-15
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for bromocriptine mesylate (Padagis US LLC).

• FDA approval · 2015-04-14
  FDA Approved: BENZTROPINE MESYLATE — Original Application (SUNRISE PHARMACEUTICAL, INC)

  FDA approved an original ANDA for Benztropine Mesylate by Sunrise Pharmaceutical, expanding generic options for Parkinsonism and extrapyrami…

• FDA approval · 2015-04-13
  FDA Approved: ROPINIROLE HYDROCHLORIDE — Supplemental Application (SOLCO HEALTHCARE US, LLC)

  The FDA approved a supplemental Abbreviated New Drug Application to authorize a generic ropinirole hydrochloride product from Solco Healthca…

• FDA approval · 2015-02-27
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Accord Healthcare, Inc.)

  The FDA approved a supplemental application for Accord Healthcare, Inc. to market a generic combination of carbidopa and levodopa.

• FDA approval · 2015-02-26
  FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for NEUPRO (rotigotine) from UCB, Inc., resulting in updated labeling. This action reflects a ch…

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• FDA approval · 2015-02-13
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Bromocriptine Mesylate by Mylan Pharmaceuticals Inc.

• FDA approval · 2015-02-06
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's supplemental application for a generic carbidopa/levodopa product, enabling marketing for Parkinson's …

• FDA approval · 2015-01-16
  FDA Approved: ENTACAPONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Entacapone submitted by Sun Pharmaceutical Industries, Inc. The drug is used as an adjunct t…

• FDA approval · 2015-01-09
  FDA Approved: DUOPA — Original Application (AbbVie Inc.)

  FDA approved DUOPA (carbidopa and levodopa) from AbbVie under its original application, a gel-delivery formulation for advanced Parkinson's …

• FDA approval · 2015-01-07
  FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved Zydus Pharmaceuticals USA Inc.'s original application for a carbidopa and levodopa product to treat Parkinson's disease.

• FDA approval · 2014-11-26
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for bromocriptine mesylate submitted by ANI Pharmaceuticals, Inc. This action updates the regula…

• FDA approval · 2014-11-04
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva Pharmaceuticals USA, Inc. for Carbidopa and Levodopa (generic) products.

• FDA approval · 2014-09-30
  FDA Approved: TASMAR — Supplemental Application (Bausch Health US LLC)

  FDA approves a supplemental application for TASMAR (tolcapone) filed by Bausch Health US LLC.

• FDA approval · 2014-07-31
  FDA Approved: ZELAPAR — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for Zelapar (selegiline hydrochloride) submitted by Bausch Health US, LLC.

• FDA approval · 2014-07-18
  FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)

  FDA approves a supplemental application for a carbidopa/levodopa/entacapone combination from Sandoz Inc for the treatment of Parkinson disea…

• FDA approval · 2014-07-17
  FDA Approved: SINEMET — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Sinemet (carbidopa/levodopa) submitted by Organon LLC.

• FDA approval · 2014-06-03
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's original application for pramipexole dihydrochloride, a generic formulation indicated for trea…

• FDA approval · 2014-05-29
  FDA Approved: AZILECT — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved a supplemental application for AZILECT (rasagiline mesylate) from Teva Neuroscience, Inc.

• FDA approval · 2014-02-27
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Bromocriptine Mesylate from ANI Pharmaceuticals, Inc., resulting in an updated approval for …

• FDA approval · 2014-02-25
  FDA Approved: BENZTROPINE MESYLATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for benztropine mesylate from Hikma Pharmaceuticals USA Inc., indicating an approved change to an ex…

• FDA approval · 2014-02-21
  FDA Approved: CARBIDOPA — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved a supplemental application for carbidopa tablets from Oceanside Pharmaceuticals.

• FDA approval · 2014-02-14
  FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for the carbidopa/levodopa/entacapone product by Sandoz Inc.

• FDA approval · 2014-01-16
  FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for the fixed-dose combination of carbidopa, levodopa, and entacapone.

• FDA approval · 2014-01-16
  FDA Approved: ENTACAPONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for entacapone submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2013-12-10
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pramipexole dihydrochloride from Torrent Pharmaceuticals Limited, authorizing a supplemental AND…