Most Read Articles
Rachel Soon, 5 days ago

On 8 August, the first town hall held by the Ministry of Health (MOH) with members of the pharmacy profession took place in Putrajaya. Over 500 pharmacists from across the country and from different areas of practice—community and hospital, public and private, academy and industry—converged to fill the auditorium for the chance to engage in direct dialogue with MOH.

Stephen Padilla, 14 Aug 2019
Early administration of recombinant human B-type natriuretic peptide (rhBNP) can lower the incidence of reperfusion injury for patients with ST-elevation myocardial infarction (STEMI) who are receiving percutaneous coronary intervention (PCI) treatment, according to a China study.
11 Aug 2019
Intraoperative methylprednisolone does not appear to significantly prevent the incidence of death, cardiac arrest and other injuries in neonates undergoing cardiac surgery with cardiopulmonary bypass, according to a recent study.
4 days ago
Pulmonary function has potential predictive value for future increases in arterial stiffness and its progression, as reported in a recent study.

Original New Drug Application Approvals by US FDA (16 - 31 August 2016)

31 Aug 2016
New drug applications approved by US FDA as of 16 - 31 August 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.

TROXYCA ER
  • Active Ingredient(s): Oxycodone hydrochloride; Naltrexone hydrochloride
  • Strength: 10MG/1.2MG; 20MG/2.4MG; 30MG/3.6MG; 40MG/4.8MG; 60MG/7.2MG; 80MG/9.6MG
  • Dosage Form: Oral capsule
  • Company: Pfizer Inc
  • Approval Date: August 19, 2016
  • Chemical Type: Not available
  • 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: 08/19/2016 (PDF)

PALONOSETRON HYDROCHLORIDE
  • Active Ingredient(s): Palonosetron hydrochloride
  • Strength: 0.125 MG/ML
  • Dosage Form: Injectable; injection
  • Company: Exela Pharma SCS LLC
  • Approval Date: August 22, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated in adults for:
    • Moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
    • Highly emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses.
  • Approved Label: 08/22/2016 (PDF)

ERELZI
  • Active Ingredient(s): Etanercept-SZZS
  • Strength: 25MG/0.5ML; 50MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Sandoz Inc
  • Approval Date: August 30, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of:
    • Rheumatoid Arthritis (RA)
    • Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older
    • Psoriatic Arthritis (PsA)
    • Ankylosing Spondylitis (AS)
    • Plaque Psoriasis (PsO)
  • Approved Label: 08/30/2016 (PDF)
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Most Read Articles
Rachel Soon, 5 days ago

On 8 August, the first town hall held by the Ministry of Health (MOH) with members of the pharmacy profession took place in Putrajaya. Over 500 pharmacists from across the country and from different areas of practice—community and hospital, public and private, academy and industry—converged to fill the auditorium for the chance to engage in direct dialogue with MOH.

Stephen Padilla, 14 Aug 2019
Early administration of recombinant human B-type natriuretic peptide (rhBNP) can lower the incidence of reperfusion injury for patients with ST-elevation myocardial infarction (STEMI) who are receiving percutaneous coronary intervention (PCI) treatment, according to a China study.
11 Aug 2019
Intraoperative methylprednisolone does not appear to significantly prevent the incidence of death, cardiac arrest and other injuries in neonates undergoing cardiac surgery with cardiopulmonary bypass, according to a recent study.
4 days ago
Pulmonary function has potential predictive value for future increases in arterial stiffness and its progression, as reported in a recent study.