New drug approvals - Oct 2020

Product Name

PECFENT NASAL SPRAY SOLUTION 100MCG/SPRAY

PECFENT NASAL SPRAY SOLUTION 400MCG/SPRAY

Active Ingredient

Fentanyl

Application type

NDA-2: New dosage form

Product Registrant

A.MENARINI SINGAPORE PTE. LTD.

Date of Approval

12/10/2020

Registration No.

SIN16026P, SIN16027P

Indications:

PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.

Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Product Name

XYZAL FILM-COATED TABLET 5 MG

Active Ingredient

Levocetirizine dihydrochloride (5 mg)

Application type

NDA-2*: New forensic classification of the 50's pack size (Split license from SIN12084P)

Product Registrant

GlaxoSmithKline Pte. Ltd.

Date of Approval

14/10/2020

Registration No.

SIN16028P

Indications:

Levocetirizine is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria.

Product Name

DARZALEX SC SOLUTION FOR INJECTION 1800MG/15ML

Active Ingredient

Daratumumab

Application type

NDA-2: New dosage form

Product Registrant

JOHNSON & JOHNSON PTE LTD

Date of Approval

27/10/2020

Registration No.

SIN16032P

Indications:

DARZALEX® SC is indicated for the treatment of patients with multiple myeloma:

• in combination with bortezomib, melphalan and prednisone, or in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant.

• in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.

• in combination with lenalidomide and dexamethasone, or in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.

• as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double-refractory to a PI and an IMiD.

Product Name

SPRAVATO NASAL SPRAY 28 MG/VIAL

Active Ingredient

Esketamine

Application type

NDA-1

Product Registrant

Johnson & Johnson Pte Ltd

Date of Approval

27 Oct 2020

Registration No.

SIN16033P

Indications:

SPRAVATO®, in combination with an oral antidepressant (SSRI or SNRI), is indicated for treatment-resistant depression (Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current depressive episode).