Most Read Articles
Jairia Dela Cruz, 09 Sep 2019
Young Singaporean women are likely to get themselves immunized against human papillomavirus (HPV) with the motivation to protect their own health, positive information about the vaccine and parental encouragement, as reported in a recent qualitative study.
Audrey Abella, 14 Aug 2019
The immunotherapeutic human papillomavirus (HPV) vaccine tipapkinogen sovacivec (TS) provided complete histologic resolution of cervical intraepithelial neoplasia (CIN) grade 2/3, offering a potential nonsurgical option for cervical precancerous lesions which could stretch to other HPV-associated precursors or cancers in the future, a new study shows.

Original New Drug Application Approvals by US FDA (16 - 30 November 2016)

30 Nov 2016
New drug applications approved by US FDA as of 16 - 30 November 2016 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

INTRAROSA
  • Active Ingredient(s): PRASTERONE
  • Strength: 6.5MG
  • Dosage Form: Vaginal insert
  • Company: Endoceutics Inc
  • Approval Date: November 16, 2016
  • Chemical Type: Type 2 New Active Ingredient and Type 4 New Combination
  • Indication(s): Indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
  • Approved Label: 11/16/2016 (PDF)

XULTOPHY
  • Active Ingredient(s): INSULIN DEGLUDEC;LIRAGLUTIDE
  • Strength: 100;3.6
  • Dosage Form: Injectable;injection
  • Company: Novo Nordisk Inc
  • Approval Date: November 21, 2016
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily)
  • Approved Label: 11/21/2016 (PDF)

SOLIQUA
  • Active Ingredient(s): INSULIN GLARGINE;LIXISENATIDE
  • Strength: 100UNITS;50MCG
  • Dosage Form: Injectable; injection
  • Company: Sanofi Aventis US
  • Approval Date: November 21, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide
  • Approved Label: 11/21/2016 (PDF)
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Most Read Articles
Jairia Dela Cruz, 09 Sep 2019
Young Singaporean women are likely to get themselves immunized against human papillomavirus (HPV) with the motivation to protect their own health, positive information about the vaccine and parental encouragement, as reported in a recent qualitative study.
Audrey Abella, 14 Aug 2019
The immunotherapeutic human papillomavirus (HPV) vaccine tipapkinogen sovacivec (TS) provided complete histologic resolution of cervical intraepithelial neoplasia (CIN) grade 2/3, offering a potential nonsurgical option for cervical precancerous lesions which could stretch to other HPV-associated precursors or cancers in the future, a new study shows.