New drug approvals - Mar 2020

Product Name

PHENYLALPHA SOLUTION FOR INJECTION 50MCG/ML

Active Ingredient

Phenylephrine hydrochloride

Application type

NDA-2: New dosage form

Product Registrant

INTEGA PTE LTD

Date of Approval

03/03/2020

Registration No.

SIN15896P

Indications:

Treatment of hypotension during general anaesthesia and locoregional anaesthesia, whether spinal or epidural, and whether for surgical or obstetric procedures.

Preventive treatment of hypotension during spinal anaesthesia for surgical or obstetric procedures.

 

Product Name

CALIBERI ORODISPERSIBLE FILM 20MG

CALIBERI ORODISPERSIBLE FILM 5MG

Active Ingredient

Tadalafil

Application type

NDA-2: New dosage form

NDA-3: New strength

Product Registrant

ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

Date of Approval

09/03/2020

Registration No.

SIN15898P, SIN15899P

Indications:

Treatment of erectile dysfunction (ED) in adult males. In order for CALIBERI ODF to be effective for the treatment of ED, sexual stimulation is required.

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED/BPH). CALIBERI ODF is not indicated for use by women.

 

Product Name

STEGLATRO FILM-COATED TABLETS 5MG

STEGLATRO FILM-COATED TABLETS 15MG

Active Ingredient

Ertugliflozin L-PGA

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

11/03/2020

Registration No.

SIN15901P, SIN15902P 

Indications:

STEGLATRO (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see 10. CLINICAL STUDIES].

 

Product Name

STEGLUJAN FILM-COATED TABLETS 5MG/100MG

STEGLUJAN FILM-COATED TABLETS 15MG/100 MG

Active Ingredient

Sitagliptin phosphate monohydrate / ertugliflozin L-PGA

Application type

NDA-2: New combination

NDA-3: New strength

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

11/03/2020

Registration No.

SIN15904P, SIN15905P 

Indications:

STEGLUJAN (ertugliflozin and sitagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate [see 10. CLINICAL STUDIES].

 

Product Name

DELSTRIGO FILM COATED TABLET

Active Ingredient

Lamivudine 100mg, Tenofovir disoproxil fumarate 300mg, Doravirine 100mg

Application type

NDA-2: New combination

Product Registrant

MSD PHARMA (SINGAPORE) PRIVATE LIMITED

Date of Approval

13 Mar 2020

Registration No.

SIN15909P

Indications:

DELSTRIGO™ is indicated for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to NNRTI, lamivudine, or tenofovir.

 

Product Name

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

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

Active Ingredient

Adalimumab

Application type

NDA-2: New strength

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

19/03/2020

Registration No.

SIN15914P, SIN15915P

Indications:

ADULTS

Rheumatoid Arthritis

Humira is 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. Humira can be used alone or in combination with methotrexate or other DMARDs.

Humira, 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

Humira is 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. Humira 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.

Humira can be used alone or in combination with DMARDs.

Ankylosing Spondylitis

Humira is 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

Humira is indicated for the treatment of moderate to severe active Crohn’s disease in adults to reduce the 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, Humira should be given in combination with corticosteroids. Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inadequate.

Ulcerative Colitis

Humira is 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

Humira is 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 Suppurativa

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

Uveitis

Humira is 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

Humira in 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). Humira 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). Humira has not been studied in patients aged less than 2 years.

Enthesitis-Related Arthritis

Humira is 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

Humira is 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

Humira is 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 Suppurativa

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

Pediatric Uveitis

Humira is indicated for the treatment of chronic non-infectious anterior uveitis in pediatric patients 2 years of age and older who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

 

Product Name

PIQRAY 250, 300 AND 200MG DAILY DOSE PACKS

Active Ingredient

Alpelisib

Application type

NDA-1 (250MG): New chemical entity

NDA-3: Subsequent strengths

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

25/03/2020

Registration No.

SIN15916P, SIN15917P and SIN15918P

Indications:

Piqray is an α-specific class I phosphatidylinositol-3-kinase (PIK3CA) inhibitor indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, HER2- negative, advanced breast cancer with a PIK3CA mutation in combination with fulvestrant after disease progression following an endocrine-based regimen.

 

Product Name

EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED PEN 120MG/ML

Active Ingredient

Galcanezumab

Application type

NDA-1: New chemical entity

Product Registrant

Eli Lilly (Singapore) Pte Ltd

Date of Approval

25/03/2020

Registration No.

SIN15919P

Indications:

Emgality Solution for Injection in Pre-filled Pen 120 mg/ml is indicated for the preventive treatment of migraine in adults.

 

 

Product Name

ALBURX SOLUTION FOR INFUSION 5%, 20%, 25%

Active Ingredient

Human albumin

Application type

NDA-2: New dosage form

NDA-3: Subsequent strengths

Product Registrant

CSL Behring Pte Ltd

Date of Approval

11/03/2020

Registration No.

SIN15903P, SIN15906P and SIN15907P

Indications:

Restoration and maintenance of circulating blood volume in cases of volume deficiency where the use of a colloid is indicated.

The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals