Most Read Articles
Roshini Claire Anthony, 04 Apr 2019

In addition to an intensive weight loss programme, the use of continuous positive airway pressure (CPAP) could improve absolute weight loss in individuals with obesity and obstructive sleep apnoea (OSA), according to a study presented at ENDO 2019.

4 days ago
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
5 days ago
Extremely premature neonates who have been exposed to pre-eclampsia in utero are at high risk of developing severe respiratory distress syndrome and severe bronchopulmonary dysplasia, according to a study.
Pearl Toh, 3 days ago
A contraceptive vaginal system (Annovera) releasing a combination of segesterone acetate and ethinyl estradiol (SA/EE) effectively inhibits ovulation up to a year even at low systemic levels of SA, reports a review study presented at ENDO 2019.

Original New Drug Application Approvals by US FDA (01 - 15 April 2019)

5 days ago
New drug applications approved by US FDA as of 01 - 15 April 2019 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.

WELCHOL
  • Active Ingredient(s): Colesevelam hydrochloride
  • Strength: 3.75 g
  • Dosage Form(s) / Route(s): Bar, chewable; Oral
  • Company: Daiichi Sankyo Inc.
  • Approval Date: 03 Apr 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as an adjunct to diet and exercise to: 
    • reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia
    • reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH)
    • improve glycemic control in adults with type 2 diabetes mellitus
  • Approved Label: 03 Apr 2019 (PDF)

DOLUTEGRAVIR; LAMIVUDINE
  • Active Ingredient(s): Dolutegravir and lamivudine
  • Strength: 50 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: ViiV Healthcare
  • Approval Date: 08 Apr 2019
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components of DOVATO
  • Approved Label08 Apr 2019 (PDF)

EVENITY
  • Active Ingredient(s): Romosozumab-aqqg
  • Strength: 105 mg/1.17 mL
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Amgen Inc.
  • Approval Date: 09 Apr 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
  • Approved Label09 Apr 2019 (PDF)

LEVOTHYROXINE SODIUM
  • Active Ingredient(s): Levothyroxine sodium
  • Strength: 100 mcg; 200 mcg; 500 mcg
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Fresenius Kabi USA
  • Approval Date: 11 Apr 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adult patients for the treatment of myxedema coma
  • Approved Label11 Apr 2019 (PDF)

BALVERSA
  • Active Ingredient(s): Erdafitinib
  • Strength: 3 mg; 4 mg; 5 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Janssen Biotech
  • Approval Date: 12 Apr 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has:
    • susceptible FGFR3 or FGFR2 genetic alterations and
    • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
  • Approved Label11 Apr 2019 (PDF)
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Most Read Articles
Roshini Claire Anthony, 04 Apr 2019

In addition to an intensive weight loss programme, the use of continuous positive airway pressure (CPAP) could improve absolute weight loss in individuals with obesity and obstructive sleep apnoea (OSA), according to a study presented at ENDO 2019.

4 days ago
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
5 days ago
Extremely premature neonates who have been exposed to pre-eclampsia in utero are at high risk of developing severe respiratory distress syndrome and severe bronchopulmonary dysplasia, according to a study.
Pearl Toh, 3 days ago
A contraceptive vaginal system (Annovera) releasing a combination of segesterone acetate and ethinyl estradiol (SA/EE) effectively inhibits ovulation up to a year even at low systemic levels of SA, reports a review study presented at ENDO 2019.