New drug approvals - April 2022

Product Name

ZEJULA FILM-COATED TABLET 100MG, 200MG, 300MG

Active Ingredient

Niraparib

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

01/04/2022

Registration No.

SIN16459P, SIN16460P, SIN16461P

Indications:

ZEJULA is indicated:

· as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

· as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. The overall survival benefit in patients without germline BRCA mutation ovarian cancer has not been demonstrated (see Clinical Studies section).

Name

HIBOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES 3500 IU ANTI-XA/0.2 ML

HIBOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES 2500IU ANTI-XA/0.2ML

Active Ingredient

Bemiparin Sodium

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

DCH AURIGA SINGAPORE

Date of Approval

01/04/2022

Registration No.

SIN16462P, SIN16463P

Indications:

Prevention of thromboembolic disease in patients (at high risk of developing VTE) undergoing total knee arthroplasty.

Product Name

B.BRAUN IBUPROFEN SOLUTION FOR INFUSION 4MG/ML

Active Ingredient

Ibuprofen

Application type

NDA-2: New dosage form

Product Registrant

B.BRAUN SINGAPORE PTE LTD

Date of Approval

04/04/2022

Registration No.

SIN16467P

Indications:

Ibuprofen B. Braun is indicated in children (≥ 5 kg body weight), adolescents and adults for the short-term symptomatic treatment of acute moderate pain, and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified, when other routes of administration are not possible.

Product Name

REBLOZYL POWDER FOR SOLUTION FOR INJECTION 25MG/VIAL AND 75MG/VIAL

Active Ingredient

Luspatercept

Application type

NDA-1: New biological entity

NDA-3: New strength

Product Registrant

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Date of Approval

06/04/2022

Registration No.

SIN16470P, SIN16471P

Indications:

Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5.1).

Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta-thalassaemia (see section 5.1).

Limitation of use

Reblozyl is not indicated for use as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anaemia

Vancomycin Hydrochloride Capsule is indicated for the treatment of C. difficile-associated diarrhea. Vancomycin Hydrochloride Capsule is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.

Limitations of Use

Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsule must be given orally for these infections.

Product Name

GONAL-F 150 IU/0.25 ML (11 MICROGRAMS/0.25 ML) SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active Ingredient

Follitropin alfa

Application type

NDA-3: New strength

Product Registrant

MERCK PTE. LTD

Date of Approval

11/04/2022

Registration No.

SIN16473P

Indications:

In adult women

• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.

• Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra- fallopian transfer.

Product Name

ALIGRIN TABLET 20MG

Active Ingredient

Bilastine

Application type

NDA-2

Product Registrant

A. MENARINI SINGAPORE PTE LTD

Date of Approval

12/04/2022

Registration No.

SIN16474P

Indications:

Symptomatic treatment of allergic rhino-conjunctivitis and urticaria.

BILAXTEN is indicated in adults and adolescents (12 years of age and over).