Most Read Articles
Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
25 Apr 2020
The human papillomavirus (HPV) DNA vaccine (GX-188E) is effective against HPV type 16/18–associated cervical intraepithelial neoplasia (CIN) 3, according to the results of a phase II trial.
Audrey Abella, 02 Jul 2020
The highly selective SGLT2 inhibitor bexagliflozin demonstrated significant efficacy and safety in controlling hyperglycaemia, weight, and blood pressure (BP) in patients with type 2 diabetes (T2D) who were at high risk of cardiovascular (CV) events, results of the BEST** trial have shown.
18 Jul 2019
In the treatment of patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC), de-escalating dose and volume of radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy appears to positively affect oncologic outcomes and reduce toxicity, according to data from the phase II OPTIMA trial.

Original New Drug Application Approvals by US FDA (16 - 31 March 2020)

31 Mar 2020
New drug applications approved by US FDA as of 16 - 31 March 2020 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.

PULMOTECH MAA
  • Active Ingredient(s): Technetium TC99M albumin aggregated
  • Strength: 2 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: CIS BIO Intl.
  • Approval Date: 20 March 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adult and pediatric patients.
    • Scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.
  • Approved Label20 March 2020 (PDF)

ZEPOSIA
  • Active Ingredient(s): Ozanimod hydrochloride
  • Strength: 0.23 mg; 0.46 mg; 0.92 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Celgene
  • Approval Date: 25 March 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • Approved Label25 March 2020 (PDF)

TRIFERIC
  • Active Ingredient(s): Ferric pyrophosphate citrate
  • Strength: 6.75 mg iron per 4.5 mL solution
  • Dosage Form(s) / Route(s): Solution; intravenous
  • Company: Rockwell Medical Inc.
  • Approval Date: 27 March 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
  • Approved Label27 March 2020 (PDF)

LEVONORGESTREL AND ETHINYL ESTRADIOL
  • Active Ingredient(s): Ethinyl estradiol; levonorgestrel
  • Strength: 0.01 mg/0.02 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Exeltis USA, Inc.
  • Approval Date: 30 March 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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Editor's Recommendations
Most Read Articles
Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
25 Apr 2020
The human papillomavirus (HPV) DNA vaccine (GX-188E) is effective against HPV type 16/18–associated cervical intraepithelial neoplasia (CIN) 3, according to the results of a phase II trial.
Audrey Abella, 02 Jul 2020
The highly selective SGLT2 inhibitor bexagliflozin demonstrated significant efficacy and safety in controlling hyperglycaemia, weight, and blood pressure (BP) in patients with type 2 diabetes (T2D) who were at high risk of cardiovascular (CV) events, results of the BEST** trial have shown.
18 Jul 2019
In the treatment of patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC), de-escalating dose and volume of radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy appears to positively affect oncologic outcomes and reduce toxicity, according to data from the phase II OPTIMA trial.