New drug approvals - July 2019

  

Product Name

AMGEVITA SOLUTION FOR INJECTION IN PREFILLED SYRINGE 40MG/0.8ML

AMGEVITA SOLUTION FOR INJECTION IN PREFILLED SYRINGE 20MG/0.4ML

AMGEVITA SOLUTION FOR INJECTION IN PREFILLED AUTOINJECTOR 40MG/0.8ML

Active Ingredient

Adalimumab

Application type

NDA-2/3: Biosimilar

Product Registrant

AMGEN SINGAPORE MANUFACTURING PTE. LTD.

Date of Approval

PFS: 02/07/2019

PF autoinjector: 31/07/2019

Registration No.

SIN15731P, SIN15732P; SIN15760P

Indications:

Adults

Rheumatoid Arthritis

Amgevitais indicated for reducing signs and symptoms and inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.Amgevita can be used alone or in combination with methotrexate or other DMARDs. Amgevita, in combination with MTX, can also be used in the treatment of patients with recently diagnosed moderate to severely active rheumatoid arthritis who have not received methotrexate.

Psoriatic Arthritis

Amgevitais indicated for reducing signs and symptoms of active arthritis in adult patients with moderate to severe psoriatic arthritis when the response to previous DMARD therapy has been inadequate.Amgevita has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.Amgevita can be used alone or in combination with DMARDs.

Ankylosing Spondylitis

Amgevitais indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Crohn’s Disease

Amgevitais indicated for the treatment of moderate to severe Crohn’s disease in adults to reduce signs and symptoms of the disease, and to induce and maintain clinical remission in patients who have had an inadequate response to conventional therapies, or who have lost response to or are intolerant of infliximab. For induction treatment,Amgevita should be given in combination with corticosteroids.Amgevita can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inadequate.

Ulcerative Colitis

Amgevitais indicated for treatment of moderately to severely active ulcerative colitis in adult patients 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.

Plaque psoriasis

Amgevitais indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate.

Hidradenitis Suppurative

Amgevitais indicated for the treatment of active moderate to severe hidradenitis suppurative (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.

Uveitis

Amgevitais indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

Pediatrics

Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis

Amgevitain combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older, who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see CLINICAL STUDIES).Amgevita has not been studied in patients aged less than 2 years.

Enthesitis-Related Arthritis

Amgevitais indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.

Pediatric Crohn’s Disease

Amgevitais indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients, 6 years of age and older, with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.

Pediatric Plaque Psoriasis

Amgevitais indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

Adolescent Hidradenitis Suppurative

Amgevitais indicated for the treatment of active moderate to severe hidradenitis suppurative (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic hidradenitis suppurative (HS) therapy.

 

Product Name

KEVZARA SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG AND 200MG

Active Ingredient

Sarilumab

Application type

NDA-2: New dosage form

NDA-3: New strength

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE LTD

Date of Approval

08/07/2019

Registration No.

SIN15737P and SIN15738P

Indications:

KEVZARA® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

 

Product Name

TEKCIS RADIONUCLIDE GENERATOR 2-50GBQ

Active Ingredient

Sodium molybdate

Application type

NDA-2

Product Registrant

QT INSTRUMENT (S) PTE LTD

Date of Approval

10/07/2019

Registration No.

SIN15741P

Indications:

This medicinal product is for diagnostic use only.

The eluate from the radionuclide generator (Sodium Pertechnetate (99mTc) Injection Ph. Eur.) is indicated for:

· Labelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such solution.

· Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in thyroid disease.

· Salivary gland scintigraphy: diagnosis of chronic sialadenitis (e.g. Sjögren Syndrom) as well as to assess salivary gland function and duct patency in salivary glands disorders and monitoring of the response to therapeutic interventions (in particular radio iodine therapy).

· Location of ectopic gastric mucosa (Meckel's diverticulum).

· Lacrimal duct scintigraphy to assess functional disorders of lacrimation and monitoring of the response to therapeutic interventions.

 

Product Name

SYMVENU® HARD CAPSULES 1.5MG, 3MG, 4.5MG, 6MG

Active Ingredient

Cariprazine

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

MITSUBISHI TANABE PHARMA SINGAPORE PTE LTD

Date of Approval

11/07/2019

Registration No.

SIN15743P, SIN15744P, SIN15745P, SIN15746P

Indications:

Symvenu® is indicated for the treatment of schizophrenia in adult patients.

 

Product Name

BESPONSA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/VIAL

Active Ingredient

Inotuzumab Ozogamicin

Application type

NDA-1

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

17/07/2019

Registration No.

SIN15747P

Indications:

Inotuzumab ozogamicin is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

 

Product Name

BAT STERILE SOLUTION FOR INJECTION

Active Ingredient

Botulism antitoxin (equine) serotypes A, B, C, D, E, F, G

Application type

NDA-1

Product Registrant

EMERGENT SALES AND MARKETING SINGAPORE PTE LTD

Date of Approval

18/07/2019

Registration No.

SIN15749P

Indications:

BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] is a mixture of immune globulin fragments indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients.

The effectiveness of BAT is based solely on efficacy studies conducted in animal models of botulism.

 

Product Name

CALQUENCE HARD CAPSULES 100MG

Active Ingredient

Acalabrutinib

Application type

NDA-1: New chemical entity

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

25/07/2019

Registration No.

SIN15753P

Indications:

CALQUENCE is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

 

Product Name

PREVYMIS FILM COATED TABLET 240MG, 480MG

PREVYMIS CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML

Active Ingredient

Letermovir

Application type

NDA 1/2/3

Product Registrant

MSD PHARMA (SINGAPORE) PTE LTD

Date of Approval

30/07/2019

Registration No.

SIN15757P, SIN15758P, SIN15759P

Indications:

PREVYMIS is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).


Healthcare professional, Therapeutic Products
Published:

New Drug Approvals