Restless Legs Syndrome

• FDA approval · 2015-08-07
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved a generic pramipexole dihydrochloride product from Dr. Reddy's Laboratories Limited; indicated for Parkinson's disease and rest…

• 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 · 2015-04-13
  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 · 2015-02-26
  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…

• 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…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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…

• FDA approval · 2013-10-29
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  The FDA approved a supplemental application for Horizant (gabapentin enacarbil) from Azurity Pharmaceuticals (formerly Arbor Pharmaceuticals…

• FDA approval · 2013-07-31
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for pramipexole dihydrochloride from Macleods Pharmaceuticals Limited. This action updates the p…

• FDA approval · 2013-05-01
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved a supplemental application for Horizant (gabapentin enacarbil) by Azurity Pharmaceuticals, Inc.

• FDA approval · 2013-04-22
  FDA Approved: ROPINIROLE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for a generic ropinirole product.

• FDA approval · 2013-03-27
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved a supplemental application for HORIZANT (gabapentin enacarbil) submitted by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharm…

• FDA approval · 2012-12-26
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved a supplemental application for Horizant (gabapentin enacarbil) submitted by Azurity Pharmaceuticals (formerly Arbor Pharmaceuti…

• FDA approval · 2012-11-28
  FDA Approved: ROPINIROLE — Original Application (Bionpharma Inc.)

  FDA approved the original application for ropinirole from Bionpharma Inc., representing a generic version of ropinirole. This marks the avai…

• FDA approval · 2012-10-31
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pramipexole dihydrochloride from Torrent Pharmaceuticals Limited.

• FDA approval · 2012-10-26
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Pramipexole dihydrochloride as a generic product, manufactured by Aurobindo Pharma Limited, for th…

• FDA approval · 2012-09-20
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for pramipexole dihydrochloride from Macleods Pharmaceuticals Limited, marking the entry of a generic …

• FDA approval · 2012-06-06
  FDA Approved: ROPINIROLE — Original Application (Dr. Reddys Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's generic ropinirole tablets via an original ANDA. Ropinirole is used to treat Parkinson's dis…

• FDA approval · 2012-05-17
  FDA Approved: ROPINIROLE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma, Inc.'s original application for ropinirole, a generic formulation used to treat Parkinson's disease and res…

• FDA approval · 2012-04-02
  FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for NEUPRO (rotigotine) from UCB, Inc.

• FDA approval · 2012-02-23
  FDA Approved: ROPINIROLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for ropinirole from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2012-02-07
  FDA Approved: ROPINIROLE — Original Application (Marlex Pharmaceuticals Inc)

  FDA approved a generic version of ropinirole (Original Application) by Marlex Pharmaceuticals Inc for use in Parkinson's disease and restles…

• FDA approval · 2011-08-29
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for a generic pramipexole dihydrochloride product from Torrent Pharmaceuticals Limited, for the trea…

• FDA approval · 2011-08-22
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for pramipexole dihydrochloride submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2011-04-06
  FDA Approved: HORIZANT — Original Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved Horizant (gabapentin enacarbil) under an original application for the treatment of restless legs syndrome in adults and posther…

• FDA approval · 2010-10-08
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's original application for pramipexole dihydrochloride tablets, a dopamine agonist for Parkinso…