Most Read Articles
3 years ago

Over the past few decades, there has been widespread concern about the increasing proportion of births born by caesarean delivery. The rising rate of primary caesarean section has led to the increased number of obstetric population with a history of prior caesarean delivery. Although this group of women may be offered planned vaginal birth after previous caesarean section (VBAC) or elective repeat caesarean section (ERCS), the VBAC rate is generally low particularly in well-developed countries. In the United States, the VBAC rate has decreased to 8.5% by 2006, while the total caesarean rate has increased to 31.1%.1

one year ago
Kidney and bladder stones (urinary tract stones) are not risk factors for osteoporosis in postmenopausal women, according to the women’s health initiative.
Lianne Cowie, 3 years ago

Tumor necrosis factor (TNF)-α inhibitors are commonly used in the treatment of inflammatory bowel disease (IBD), but the effects of these agents on pregnancy outcomes remain unclear. Now, a systematic review of the English literature has indicated that they pose little risk to the mother or her infant, even if use is continued through the third trimester.

one year ago
A study on participants from the Women's Health Initiative showed the dissociation between calcium/vitamin D supplementation and reduction in menopausal symptoms.

Original New Drug Application Approvals by US FDA (1 - 15 May 2017)

12 days ago
New drug applications approved by US FDA as of 1 - 15 May 2017 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.

STERITALC
  • Active Ingredient(s): TALC
  • Strength: 2MG, 3MG, 4MG
  • Dosage Form: Topical Powder
  • Company: Novatech SA
  • Approval Date: May 1, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.
    • In adults to decrease the recurrence of pneumothorax
  • Approved Label: 05/01/2017 (PDF)

IMFINZI
  • Active Ingredient(s): DURVALUMAB
  • Strength: 50MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Astrazeneca UK Ltd
  • Approval Date: May 1, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of patients with:
    • Locally advanced or metastatic urothelial carcinoma who:
      • have disease progression during or following platinum-containing chemotherapy
      • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Approved Label: 05/01/2017 (PDF)

KISQALI; FEMARA
  • Active Ingredient(s): LETROZOLE;RIBOCICLIB
  • Strength: 200MG
  • Dosage Form: Oral Tablet
  • Company: Novartis Pharms Corp
  • Approval Date: May 4, 2017
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • Approved Label: 05/04/2017 (PDF)

RADICAVA
  • Active Ingredient(s): EDARAVONE
  • Strength: 30MG/100ML
  • Dosage Form: Injectable; Injection
  • Company: Mitsubishi Tanabe Pharma Development America Inc
  • Approval Date: May 5, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS)
  • Approved Label: 05/05/2017 (PDF)

MINOLIRA
  • Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
  • Strength: 105MG, 135MG
  • Dosage Form: Extended release oral tablet
  • Company: Dr Reddys Labs Ltd
  • Approval Date: May 8, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older
  • Approved Label: 05/05/2017 (PDF)

BAVENCIO
  • Active Ingredient(s): AVELUMAB
  • Strength: 20MG/ML
  • Dosage Form: Injectable; Intravenoues
  • Company: EMD Serono Inc
  • Approval Date: May 9, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of:
    • Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC)
    • Patients with locally advanced or metastatic urothelial carcinoma (UC) who:
      • Have disease progression during or following platinum-containing chemotherapy
      • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Approved Label: 05/09/2017 (PDF)
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Most Read Articles
3 years ago

Over the past few decades, there has been widespread concern about the increasing proportion of births born by caesarean delivery. The rising rate of primary caesarean section has led to the increased number of obstetric population with a history of prior caesarean delivery. Although this group of women may be offered planned vaginal birth after previous caesarean section (VBAC) or elective repeat caesarean section (ERCS), the VBAC rate is generally low particularly in well-developed countries. In the United States, the VBAC rate has decreased to 8.5% by 2006, while the total caesarean rate has increased to 31.1%.1

one year ago
Kidney and bladder stones (urinary tract stones) are not risk factors for osteoporosis in postmenopausal women, according to the women’s health initiative.
Lianne Cowie, 3 years ago

Tumor necrosis factor (TNF)-α inhibitors are commonly used in the treatment of inflammatory bowel disease (IBD), but the effects of these agents on pregnancy outcomes remain unclear. Now, a systematic review of the English literature has indicated that they pose little risk to the mother or her infant, even if use is continued through the third trimester.

one year ago
A study on participants from the Women's Health Initiative showed the dissociation between calcium/vitamin D supplementation and reduction in menopausal symptoms.