New drug indication approval - December 2021

Product Name

SPRAVATO NASAL SPRAY 28MG/VIAL

Active Ingredient

Esketamine HCl

Product Registrant

JOHNSON & JOHNSON PTE. LTD.

Date of Approval

08/12/2021

Indications:

SPRAVATO®, co-administered with oral antidepressant therapy, is indicated in adults with a moderate to severe episode of Major Depressive Disorder, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.

See Clinical Studies for a description of the populations studied.

Product Name

HUMIRA SOLUTION FOR INJECTION 20MG/0.2ML (PRE-FILLED SYRINGE)

HUMIRA SOLUTION FOR INJECTION 40MG/0.8ML (PRE-FILLED SYRINGE)

HUMIRA SOLUTION FOR INJECTION 40MG/0.4ML (PRE-FILLED SYRINGE)

HUMIRA SOLUTION FOR INJECTION 80MG/0.8ML (PREFILLED SYRINGE)

HUMIRA SOLUTION FOR INJECTION 40MG/0.8ML (VIAL)

HUMIRA SOLUTION FOR INJECTION 40MG/0.8ML (PRE-FILLED PEN)

HUMIRA SOLUTION FOR INJECTION 40MG/0.4ML (PRE-FILLED PEN)

HUMIRA SOLUTION FOR INJECTION 80MG/0.8ML (PREFILLED PEN)

Active Ingredient

Adalimumab

Product Registrant

ABBVIE PTE LTD

Date of Approval

22/12/2021

Indications:

Paediatric Ulcerative Colitis

Humira is indicated for inducing and maintaining clinical remission in paediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.