Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
Natalia Reoutova, 07 Jan 2020

A prospective cohort study of mothers taking antiepileptic drugs (AEDs) and their breastfed infants has found substantially lower AED concentrations in infant vs maternal blood, with nearly half of all obtained AED concentrations in nursing infants being less than the lower limit of quantification (LLoQ).

6 days ago
Testosterone treatment may slightly improve sexual functioning and quality of life in men without underlying organic causes of hypogonadism, but it offers little to no benefit for other common symptoms of ageing, according to a study. In addition, long-term efficacy and safety of this therapy remain unknown.

Original New Drug Application Approvals by US FDA (16 - 31 January 2017)

31 Jan 2017
New drug applications approved by US FDA as of 16 - 31 January 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.

VANTRELA ER
  • Active Ingredient(s): HYDROCODONE BITARTRATE
  • Strength: 15MG; 30MG; 45MG; 60MG; 90MG
  • Dosage Form: Extended-release oral tablet
  • Company: Teva Branded Pharm
  • Approval Date: January 17, 2017
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
  • Approved Label: 01/17/2017 (PDF)

TRULANCE
  • Active Ingredient(s): PLECANATIDE
  • Strength: 3MG
  • Dosage Form: Oral tablet
  • Company: Synergy Pharms Inc
  • Approval Date: January 19, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated in adults for treatment of chronic idiopathic constipation (CIC)
  • Approved Label: 01/19/2017 (PDF)

TEPADINA
  • Active Ingredient(s): THIOTEPA
  • Strength: 15MG/VIAL; 100MG/VIAL
  • Dosage Form: Injectable; Injection
  • Company: Adienne SA
  • Approval Date: January 26, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for
    • To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia
    • For treatment of adenocarcinoma of the breast or ovary
    • For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities
    • For treatment of superficial papillary carcinoma of the urinary bladder
  • Approved Label: 01/26/2017 (PDF)

ARMONAIR RESPICLICK
  • Active Ingredient(s): FLUTICASONE PROPIONATE
  • Strength: 55MCG; 113MCG; 232MCG
  • Dosage Form: Inhalation powder
  • Company: Teva Pharms
  • Approval Date: January 27, 2017
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated for maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older
  • Approved Label: 01/27/2017 (PDF)

AIRDUO RESPICLICK
  • Active Ingredient(s): FLUTICASONE PROPRIONATE; SALMETEROL
  • Strength: 55;14MCG, 113;14MCG, 232;14MCG
  • Dosage Form: Inhalation powder
  • Company: Teva Pharms
  • Approval Date: January 27, 2017
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated for treatment of asthma in patients aged 12 years and older
  • Approved Label: 01/27/2017 (PDF)

CORPHEDRA
  • Active Ingredient(s): EPHEDRINE SULFATE
  • Strength: 50MG/ML
  • Dosage Form: Injectable;Injection
  • Company: Par Sterile Products
  • Approval Date: January 27, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia
  • Approved Label: 01/27/2017 (PDF)

VYVANSE
  • Active Ingredient(s): LISDEXAMFETAMINE DIMESYLATE
  • Strength: 10MG
  • Dosage Form: Oral chewable tablet
  • Company: Shire Dev LLC
  • Approval Date: January 28, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of:
    • Attention Deficit Hyperactivity Disorder (ADHD)
    • Moderate to Severe Binge Eating Disorder (BED) in adults
  • Approved Label: 01/28/2017 (PDF)

XYZAL ALLERGY 24HR
  • Active Ingredient(s): LEVOCETIRZIZINE DIHYDROCHLORIDE
  • Strength: 5MG
  • Dosage Form: Oral tablet
  • Company: Sanofi-Aventis US
  • Approval Date: January 31, 2017
  • Chemical Type: Type 8 - Partial Rx to OTC Switch
  • Indication(s): Indicated for temporarily relief of these symptoms due to hayfever or other respiratory allergies:
    • Runny nose
    • Sneezing
    • Itchy, watery eyes
    • Itching of the nose or throat
  • Approved Label: 01/31/2017 (PDF)

XYZAL ALLERGY 24HR
  • Active Ingredient(s): LEVOCETIRIZINE DIHYDROCHLORIDE
  • Strength: 2.5MG/5ML
  • Dosage Form: Oral solution
  • Company: Sanofi-Aventis US
  • Approval Date: January 31, 2017
  • Chemical Type: Type 8 - Partial Rx to OTC Switch
  • Indication(s): Indicated for temporarily relief of these symptoms due to hayfever or other respiratory allergies:
    • Runny nose
    • Sneezing
    • Itchy, watery eyes
    • Itching of the nose or throat
  • Approved Label: 01/31/2017 (PDF)
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Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
Natalia Reoutova, 07 Jan 2020

A prospective cohort study of mothers taking antiepileptic drugs (AEDs) and their breastfed infants has found substantially lower AED concentrations in infant vs maternal blood, with nearly half of all obtained AED concentrations in nursing infants being less than the lower limit of quantification (LLoQ).

6 days ago
Testosterone treatment may slightly improve sexual functioning and quality of life in men without underlying organic causes of hypogonadism, but it offers little to no benefit for other common symptoms of ageing, according to a study. In addition, long-term efficacy and safety of this therapy remain unknown.