Nocturnal Enuresis

• CLINICAL_TRIALS trial_result · 2011-05-19
  Clinical Trial Update: Desmopressin Response in the Young [Phase 3]

  This Phase 3 trial evaluating desmopressin response in young patients with primary nocturnal enuresis has completed. The sponsor is Ferring …

• CLINICAL_TRIALS trial_result · 2011-05-19
  Clinical Trial Update: A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis [Phase 4]

  This document reports the completion of a Phase 4 study evaluating oral desmopressin in previously untreated children aged 5 to 15 years wit…

• CLINICAL_TRIALS trial_result · 2011-05-19
  Clinical Trial Update: A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE) [Phase 4]

  Phase 4 open-label cross-over trial in children/adolescents with primary nocturnal enuresis evaluated two daily doses of Minirin oral lyophi…

• FDA approval · 2010-04-16
  FDA Approved: IMIPRAMINE PAMOATE — Original Application (Hikma Pharmaceuticals USA Inc)

  FDA approves the original application for Imipramine Pamoate (generic) from Hikma Pharmaceuticals USA Inc. for use in treating depression an…

• FDA approval · 2010-04-16
  FDA Approved: IMIPRAMINE PAMOATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' imipramine pamoate as an Original Application (generic) under the ANDA process for the same indications …

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• FDA approval · 2010-03-11
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approval of a new generic imipramine hydrochloride product from Lupin Pharmaceuticals (ANDA 090441).

• FDA approval · 2009-03-27
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  FDA approved a supplemental application for Desmopressin Acetate submitted by Meitheal Pharmaceuticals Inc.

• FDA approval · 2008-09-03
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Desmopressin Acetate from Apotex Corp., indicating an addition or modification to the approved p…

• FDA label_change · 2008-04-25
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Bauch & Lomb Incorporated)

  FDA approved a supplemental application for Desmopressin Acetate from Bauch & Lomb Incorporated, indicating changes to labeling or related r…

• FDA approval · 2008-03-11
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Desmopressin Acetate from Apotex Corp., updating the approved generic product. The action formal…

• FDA approval · 2008-02-20
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for imipramine hydrochloride (generic) from Strides Pharma Science Limited, authorizing a modifi…

• FDA approval · 2008-02-20
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for imipramine hydrochloride from Strides Pharma Science Limited. This is a supplemental approval fo…

• FDA approval · 2007-10-26
  FDA Approved: DDAVP — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for DDAVP (desmopressin acetate) from Ferring Pharmaceuticals Inc., updating the product's labeling.

• FDA approval · 2007-06-25
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for imipramine hydrochloride from Strides Pharma Science Limited. The approval covers the continued …

• FDA approval · 2007-05-23
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Desmopressin Acetate submitted by Apotex Corp. under an ANDA.

• FDA approval · 2006-12-03
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA granted a supplemental approval for Desmopressin Acetate from Apotex Corp. under an ANDA, authorizing its generic product.