New drug approvals - January 2022

Product Name

CONTRAVE PROLONGED RELEASE TABLET 8MG/90MG

Active Ingredient

Naltrexone hydrochloride / bupropion hydrochloride

Application type

NDA-2: New combination

Product Registrant

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Date of Approval

03/01/2022

Registration No.

SIN16411P

Indications:

CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

• 30 kg/m² or greater (obese) or

• 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Limitations of Use:

• The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established (see Warnings and Precautions, Increase in Blood Pressure and Heart Rate).

• The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Product Name

CIBINQO FILM COATED TABLETS 50MG, 100MG, 200MG

Active Ingredient

Abrocitinib

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

05/01/2022

Registration No.

SIN16412P, SIN16413P, SIN16414P

Indications:

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults (age 18 years and above) who are candidates for systemic therapy and whose disease is not adequately controlled with topical medications or for whom topical treatments are otherwise medically inadvisable.

*Evaluated via Access

Product Name

SALONPAS DICLOFENAC GEL 1%

Active Ingredient

Diclofenac

Application type

NDA-2: New dosage form

Product Registrant

HISAMITSU PHARMACEUTICAL CO., INC SINGAPORE BRANCH

Date of Approval

17/01/2022

Registration No.

SIN16418P

Indications:

For relief of aches, pains and inflammation associated with: muscle pain, stiff shoulder, backache, bruises, sprains, strains, joint pain, tendons inflammation, elbow pain

Product Name

TRODELVY POWDER FOR SOLUTION FOR INFUSION 180 MG/VIAL

Active Ingredient

Sacituzumab govitecan

Application type

NDA-1: New biological entity

Product Registrant

EVEREST MEDICINES (SINGAPORE) PTE. LTD.

Date of Approval

31/01/2022

Registration No.

SIN16425P

Indications:

TRODELVY is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.