2020-drug-update-all.pdf - KMCH Institute of Health Sciences ...

D E P A R T M E N T O F P H A R M A C O L O G Y , K M C H I H S R

NEW DRUG UPDATE SERIES 6 JAN 2020

NEW DRUG UPDATE SERIES 4, NOV 2019

1.

SERIES 6

JAN 2020 DEPARTMENT OF PHARMACOLOGY- NEW DRUG UPDATE

Strive for Novelty

KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH

(A unit of Kovai Medical Centre and Hospital Limited)

Coimbatore, Tamilnadu

Contents

FDA – NEW DRUG APPROVALS

1. Golodirsen

2. Enfortumab vedotin-ejfv

3. Brilliant Blue G Ophthalmic Solution

4. Lumateperone tosylate

5. Lemborexant

6. Fam-trastuzumab deruxtecan-nxki

7. Ubrogepant

D E P A R T M E N T O F P H A R M A C O L O G Y , K M C H I H S R

NEW DRUG UPDATE SERIES 6 JAN 2020

S.No Drug Name Mechanism of Action Indications Adverse Drug

Reactions

Dosage

Formulation

Date of

FDA

Approval 1. Golodirsen An antisense

oligonucleotide. Binds to

exon 53 of dystrophin

pre-mRNA exclusion

of exon 53

Duchenne muscular

dystrophy with

mutation of the DMD

gene that is amenable

to exon 53 skipping

Headache, pyrexia,

fall, abdominal pain,

nasopharyngitis,

cough, vomiting, and

nausea

Intravenous

Injection

12/12/2019

2. Enfortumab

vedotin-ejfv

Nectin-4-directed IgG1

antibody and

microtubule inhibitor

conjugate

Locally advanced or

metastatic refractory

urothelial cancer

Fatigue, peripheral

neuropathy, loss of

appetite, rash,

alopecia, nausea, dry

eye, diarrhea

Intravenous

Injection

18/12/2019

3. Brilliant Blue

G Ophthalmic

Solution

Selectively stain the

internal limiting

membrane

Dye used in eye

surgery to selectively

stain the internal

limiting membrane

Due to surgical

procedure - retinal

- break, tear,

hemorrhage,

detachment &

cataract

Intraocular

Injection

20/12/2019

4. Lumateperone

tosylate

5-HT2A antagonism and

central D2 postsynaptic

antagonism

An atypical

antipsychotic to treat

schizophrenia

Somnolence /

sedation and dry

mouth (No EPS &

Metabolic syndrome)

Capsule 20/12/2019

5. Lemborexant Orexin receptor

antagonist

Insomnia with sleep

onset and/or sleep

maintenance difficulty

Somnolence Tablet 20/12/2019

6.

Fam-

trastuzumab

deruxtecan-

nxki

HER2-directed antibody

and topoisomerase

inhibitor conjugate

Unresectable or

metastatic refractory

HER2-positive breast

cancer

Nausea, alopecia,

constipation or

diarrhea, loss of

appetite, anemia,

pancytopenia and

cough

Intravenous

Injection

20/12/2019

7. Ubrogepant Calcitonin gene-related

peptide receptor

antagonist

Acute treatment of

migraine with or

without aura in adults

Nausea and

somnolence

Tablet 23/12/2019

COMPILED & EDITED by

Department of Pharmacology

KMCHIHSR, Coimbatore, 641014

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D E P A R T M E N T O F P H A R M A C O L O G Y , K M C H I H S R Page 1

NEW DRUG UPDATE SERIES 7 FEB 2020


1.

SERIES 7

FEB 2020 DEPARTMENT OF PHARMACOLOGY- NEW DRUG UPDATE

S.No Drug Name Mechanism

of Action Indications

Adverse Drug

Reactions

Dosage

Formulation

Date of

FDA

Approval

1. Avapritinib Tyrosine

kinase

inhibition

Unresectable or

metastatic

Gastrointestinal

stromal tumor

harboring a platelet-

derived growth

factor receptor

alpha exon 18

mutation

Edema, nausea,

fatigue/asthenia,

cognitive impairment,

vomiting, decreased

appetite, diarrhea, hair

color changes, increased

lacrimation, abdominal

pain, constipation, rash

and dizziness.

Tablet 09/01/2020

2. Teprotumumab-trbw Insulin-like

growth

factor-1

receptor

inhibition

Thyroid eye disease Muscle spasm, nausea,

alopecia, diarrhea,

fatigue, headache

hyperglycemia, hearing

impairment, dry skin,

dysgeusia

Intravenous

Injection –

Lyophilized

powder in a

single vial for

reconstitution

21/01/2020

3. Tazemetostat Histone

methyl

transferase

inhibition

Locally advanced

Epithelioid sarcoma

in adults and

pediatric patients

aged 16 years and

older

Pain, fatigue, nausea,

decreased appetite,

vomiting, and constipation

Tablet 23/01/2020





(A unit of Kovai Medical Centre and Hospital Limited)



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Strive For Novelty




New drug update Series 8 March 2020


1.

DEPARTMENT OF PHARMACOLOGY- NEW DRUG UPDATE SERIES 8

MARCH 2020


(A unit of Kovai Medical Center and Hospital Limited)


Creating the Future

Inside this series

New Drug Approvals by FDA

1. Eptinezumab-jjmr

2. Bempedoic acid

3. Amisulpride

4. Bempedoic acid and Ezetimibe

5. Rimegepant

New drugs

Available drugs with new formulation


New drug update Series 8 March 2020

1. Eptinezumab-jjmr

• Date of Approval: February 21, 2020

• Mechanism of action: Monoclonal antibody - CGRP antagonist

• Indication: Preventive treatment of Migraine in adults

• Dosage Formulation: Injection for Intravenous use

2. Bempedoic acid


• Mechanism of action: First-in-class, Adenosine triphosphate-citrate lyase inhibitor

• Indication: Heterozygous Familial Hypercholesterolemia

• Dosage Formulation: Tablet

3. Amisulpride


• Mechanism of action: Dopamine antagonist

• Indication: Post-Operative Nausea & Vomiting

• Dosage Formulation: Injection for Intravenous Infusion

4. Bempedoic acid and Ezetimibe

•Date of Approval: February 26, 2020

•Mechanism of action: Adenosine triphosphate-citrate lyase inhibitor and a cholesterol absorption inhibitor combination

•Indication: Heterozygous Familial Hypercholesterolemia

•Dosage Formulation: Tablet

5. Rimegepant


• Mechanism of action: Calcitonin gene-related peptide receptor antagonist

• Indication: Acute treatment of Migraine

• Dosage Formulation: Orally Disintegrating Tablet


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D e p a r t m e n t o f P h a r m a c o l o g y , K M C H I H S R 1| P a g e

KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH (A unit of Kovai Medical Center and Hospital Limited)

Coimbatore, Tamil Nadu

Department Of Pharmacology

New Drug Update (New Drugs and Available Drugs with New Formulation)

Series - 9 April 2020

In this series

New drugs approved by FDA

1. Isatuximab-irfc

2. Bimatoprost Implant

3. Osilodrostat

4. Ozanimod

1.Isatuximab-irfc

Date of Approval: March 2, 2020

Mechanism of action: CD38-directed cytolytic antibody

Indication: Multiple Myeloma in combination with

Pomalidomide and Dexamethasone

Dosage Formulation: IV Infusion

2.Bimatoprost Implant


Mechanism of action: PG-F2α analogue, reduces IOP

Indication: Open Angle Glaucoma

Dosage Formulation: Intra-cameral, Biodegradable

Sustained-Release Implant

3.Osilodrostat (Received Orphan Drug Designation)


Mechanism of action: Cortisol synthesis inhibitor

Indication: Adults with Cushing's Syndrome who cannot

undergo pituitary gland surgery or have undergone

surgery

Dosage Formulation: Tablet

4.Ozanimod


Mechanism of action: Sphingosine 1-phosphate receptor

modulator

Indication: Relapsing Multiple Sclerosis

Dosage Formulation: Capsule

Every Day, A New

Discovery



KMCHIHSR, Coimbatore.

****************************************************


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641014


KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH(A unit of Kovai Medical Center and Hospital Limited)

Coimbatore,Tamilnadu

Department of PharmacologyNew drug update

Inside the series

❖ Sacituzumab-govitecan-hziy

❖ Coagulation factor VIIa

recombinant-jncw

❖ Selumetinib

❖ Tucatinib

❖ Opicapone

❖ Pemigatinib

❖ Ephedrine sulphate (premixed

formulation)

❖ Mitomycin(pyelocalyceal

solution)

Compiled & Edited by

Department of

Pharmacology,

KMCHIHSR,

Coimbatore,

641014.

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Suggestions To:

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kmchihsr.edu.in

a

Department of Pharmacology, KMCHIHSR PAGE 1

Series 10May 2020

A passion for better medicine

Access this series through the KMCH

website www.kmchihsr.edu.in

Sacituzumab-govitecan-hziy

Approval date –April 22, 2020

Mechanism of

action

Indication

Dosage

formulation

Coagulation factor VIIa recombinant-jncw


Mechanism of

action

Indication

Dosage

formulation

Selumetinib


Mechanism of

action

Indication

Dosage

formulation

Pemigatinib


Tucatinib


Mechanism of

action

Mechanism of

action

Indication

Indication

Dosage

formulation

Dosage

formulation

Department of Pharmacology, KMCHIHSR PAGE 2

Opicapone


Mechanism of

action

Indication

Dosage

formulation

Trop-2-directed antibody and

topoisomerase inhibitor

conjugatePreviously-treated metastatic

Triple-Negative Breast Cancer

(mTNBC)

IV infusion (as Lyophilized

powder for reconstitution)

Coagulation factor VIIa

concentrate

Patients aged 12 years and older

with Hemophilia A or B with

inhibitors

IV injection (as Lyophilized

powder for reconstitution)

A mitogen activated protein

kinases1&2(MEK1/2)inhibitor

Paediatric patients aged 2 years &

older with symptomatic inoperable

Neurofibromatosis 1(NF1)

Capsule

A kinase inhibitor

Patients with advanced metastatic

HER2 +ve Breast carcinoma along

with trastuzumab &capecitabine

Tablet

A catechol O methyl

transferase(COMT) inhibitor

Parkinsons disease patients with

‘off’ episodes as an adjunct to

levodopa/ carbidopa

Capsule

A fibroblast growth factor

receptor(FGFR)inhibitor

Adults with unresectable locally

advanced /metastatic

Cholangiocarcinoma

Tablet

Ephedrine sulphate


Mechanism of

action

Indication

Dosage

formulation

Alpha and beta adrenergic agonist

and a norepinephrine releasing

agent

Clinically important Hypotension

occurring in the setting of

anaesthesia.

I.V. injection (available as a

premixed formulation)

Mitomycin


Mechanism of

action An alkylating agent

Indication Adult patients with Low grade

upper tract Urothelial cancer

(LG-UTUC)

Solution (Pyelocalyceal

administration)

Dosage

formulation

KMCH Institute of Health sciences and Research, Coimbatore Dept of Pharmacology

The purpose of this issue is to provide specialized and consistent source of information regarding the newly approved

drugs, to all the Health care professionals.

Issue 11

June 2020

Pharma Wins Product!! I N S I D E T H I S I S S U E :

New Drug Update

Class of drug

Combination of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin.

Indication

Heavy menstrual bleeding due to uterine fibroids in premenopausal women

Dosage formulation

Capsule


Date of

Approval

Elagolix/Estradiol/Norethindrone acetate and Elagolix

Date of

Approval

Minocycline Celecoxib

Date of

Approval

Class of drug

NSAID

Indication

Acute treatment of

migraine

Dosage

formulation

Oral solution

MAY

Latest formulation

Latest drugs

Ancient drug –

new uses

Class of drug

Topical tetracycline

Indication Inflammatory acne rosacea -adults

Dosage

formulation Topical foam

New drug update, Dept of Pharmacology, KMCHIHSR

Page 2

Class of drug

Radioactive diagnostic agent

Indication

PET imaging agent-

recurrent /metastatic cancer

Dosage formulation

IV injection

Flortaucipir F18

Date of

Approval

Class of drug

Radioactive diagnostic

agent

Indication: PET

imaging, to estimate the

neurofibrillary tangles in

adult patients with

Alzheimer’s disease

Dosage formulation IV injection

Doage

Artesunate

Class of drug

Antimalarial

Indication

Initial treatment of

severe malaria in adult

and paediatric patients

Dosage formulation

IV Injection

Date of

Approval

Lactic & citric acid, K+ bitartrate

Class of drug

Non hormonal vaginal

gel

Indication

Contraceptive

Dosage formulation

Vaginal gel

Date of

Approval

Apomorphine hydrochloride

Date of

Approval

Class of drug Dopamine agonist

Indication

OFF episodes of

Parkinson's Disease

Dosage formulation

Sublingual film

Date of

Approval

Ripretinib

Class of drug

Broad-spectrum KIT

and PDGFRα inhibitor

Indication :4th line

treatment in GIST

Dosage formulation

Tablet

Date of

Approval

Fluoroestradiol F18

MAY

MAY

MAY MAY

Do you know?

FDA drug

approval process

Discovery/concept

Preclinical research

Clinical research

FDA review

FDA post-market

safety monitoring

New drug update, Dept of Pharmacology, KMCHIHSR Page 3

Selpercatinib

Date of

Approval

Class of drug

Kinase inhibitor

Indication

Non-small cell lung

cancer, medullary

thyroid cancer

Dosage formulation

Capsule

Capmatinib

Class of drug

Kinase inhibitor

Indication

Metastatic non-small

cell lung cancer with

MET ex14

Dosage

formulation

Tablet

Daratumumab and

Hyaluronidase-fihj

Leuprolide acetate

Date of

Approval

Date of

Approval

Class of drug

Combination of

daratumumab, a CD38-

directed cytolytic

antibody&

hyaluronidase, an

endoglycosidase

Indication

Adult patients with

multiple myeloma

Dosage formulation

Subcutaneous injection

Date of

Approval

Class of drug

GnRH agonist

Indication

Pediatric patients

aged 2 years & older

with central

precocious puberty

Dosage

formulation

Injectable

suspension

MAY

MAY MAY

MAY

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Dept of Pharmacology

KMCHIHSR,

Coimbatore. 641014



KMCH Institute of Health sciences and Research, Coimbatore


Issue 12

July 2020 New Drug Update

Pharma Wins Product!! The purpose of this issue is to provide specialized

and consistent source of information regarding the

newly approved drugs, to all the Health care

professionals.

INSIDE THIS

ISSUE:

New drugs

approved by FDA

Triheptanoin

Date of

Approval

Class of drug

Medium-chain

triglyceride indicated

as a source of

calories and fatty

acids

Indication

Treatment of pediatric and

adult patients with molecularly

confirmed long-chain fatty

acid oxidation disorders (LC-

FAOD)

Dosage formulation

Oral Solution

Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf

Date of

Approval

Class of drug

Combination of two

HER2/neu receptor

antagonists and the

endoglycosidase

hyaluronidase

Indication

Treatment of early and

metastatic HER2-positive

breast cancer

Dosage formulation

S/C Injection

Latest

formulation

Latest drugs

Ancient drug –

new uses


Class of drug

Somatostatin analog

Indication

Long-term treatment of acromegaly

Dosage

formulation

Delayed release Capsule

Date of

Approval

Octreotide

Metoclopramide

Date of

Approval

Class of drug

Prokinetic agent

Indication

Acute and

recurrent

diabetic

gastroparesis in

adults

Dosage

formulation

Nasal spray

Do you know?

FDA drug

approval

process

Discovery/con

cept

Preclinical

research

Clinical

research FDA

review

FDA post-

market

safety

monitoring

Fenfluramine

Date of

Approval

Class of drug

Amphetamine derivative

Indication

Treatment of seizures associated with Dravet syndrome

Dosage

formulation

Oral Solution

Lurbinectedin

Date of

Approval

Class of drug

Selective

oncogenic

transcription

inhibitor

Indication

Adult patients with

metastatic small

cell lung cancer

(SCLC)

Dosage

formulation

IV Injection


Insulin lispro-aabc

Date of

Approval

Class of drug

Anti diabetic agent

Indication

Type 1 & 2 diabetes

mellitus

It is novel formulation of

insulin lispro, developed

to speed the absorption

of insulin into the blood

stream and reduce A1C

levels

Date of

Approval

Class of drug

PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim)

Indication

Febrile neutropenia in patients treated with chemotherapy

Dosage

formulation

S/C Injection

Pegfilgrastim-apgf

Inebilizumab-cdon

Date of

Approval

Class of drug

CD19-directed

cytolytic antibody

Indication

Neuromyelitis optica

spectrum disorder

(NMOSD) in adult

patients who are

anti-aquaporin-4

(AQP4) antibody

positive

Dosage

formulation

IV Injection

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hihsr.edu.in

Compiled & Edited by Dept of Pharmacology

KMCHIHSR,

Coimbatore. 641014

As rapid-acting mealtime

insulin, it controls high

blood sugar levels after

meals in adults

Dosage formulation

S/C & IV Injection




1 | P a g e

Compiled & Edited by: Department of Pharmacology, KMCHIHSR, Coimbatore.

Kindly Mail Your Suggestions To: [email protected]

KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH (A unit of Kovai Medical Center and Hospital Limited)


Department Of Pharmacology


Series - 13

August 2020


1. Fostemsavir

2. Remimazolam

3. Adalimumab-fkjp (Biosimilar) 4. Collagenase clostridium histolyticum-aaes

5. Decitabine and cedazuridine

6. Oxymetazoline hydrochloride

7. Calcipotriene and betamethasone dipropionate

8. Calcium, magnesium, potassium, and sodium oxybates

9. Budesonide/glycopyrrolate/formoterol fumarate

10. Abametapir

11. Brexucabtagene autoleucel

12.Tafasitamab-cxix

New drugs approved by CDSCO

13. Favipiravir

14. n-alkyl dimethyl benzyl ammonium chloride

Every Day, A New

Discovery


2 | P a g e



1. Fostemsavir

Date of Approval: July 2, 2020

Mechanism of action: Converted into active form temsavir and inhibits gp120-directed

attachment of HIV

Indication: HIV Infection type 1

Dosage Formulation: Extended-Release Tablets

2. Remimazolam

Date of Approval: , July 2, 2020

Mechanism of action: Potentiate the effects of GABAA-receptor (ultrashort acting

benzodiazepine)

Indication: Induction and maintenance of anaesthesia for short procedures

Dosage Formulation: IV injection

3. Adalimumab-fkjp (Biosimilar)


Mechanism of action: Tumor necrosis factor - α blocker

Indication: Rheumatoid arthritis, Juvenile idiopathic arthritis, Psoriatic arthritis,

Ankylosing spondylitis, Crohn's disease, Ulcerative colitis, Plaque psoriasis

Dosage Formulation: Subcutaneous injection

4. Collagenase clostridium histolyticum-aaes


Mechanism of action: Protease enzymes, hydrolyze collagen's triple-helical conformation

and lyses collagen deposits

Indication: Moderate to severe cellulite

Dosage Formulation: Intralesional injection

5. Decitabine and cedazuridine


Mechanism of action: Nucleoside metabolic inhibitor and cytidine deaminase inhibitor

Indication: Myelodysplastic syndromes


6. Oxymetazoline hydrochloride

Date of Approval: July 8 , 2020

Mechanism of action: α2-adrenergic receptor agonist

Indication: Blepharoptosis

Dosage Formulation: 0.1% Ophthalmic solution


3 | P a g e



7. Calcipotriene and betamethasone dipropionate


Mechanism of action: Vitamin D analogue, and corticosteroid combination. Reduces redness,

thickening, and scaling of the skin

Indication: Plaque psoriasis

Dosage Formulation: Cream

8. Calcium, magnesium, potassium, and sodium oxybates


Mechanism of action: Hypothesized that action is mediated through GABAB actions during

sleep at noradrenergic and dopaminergic neurons

Indication: Narcolepsy

Dosage Formulation: Oral solution

9. Budesonide/glycopyrrolate/formoterol fumarate


Mechanism of action: Combination of corticosteroid, muscarinic antagonist, beta agonist

Indication: Maintenance therapy in COPD

Dosage Formulation: Metered dose inhaler

10. Abametapir


Mechanism of action: Metalloproteinase inhibitor. Inhibits egg development and survival of

lice

Indication: Head lice infestation

Dosage Formulation: Lotion

11. Brexucabtagene autoleucel


Mechanism of action: First cell based gene therapy. CD19-directed genetically modified

autologous T cell immunotherapy

Indication: Used in combination with lenalidomide for diffuse large B-cell lymphoma

Dosage Formulation: IV infusion

12. Tafasitamab-cxix


Mechanism of action: CD19-directed cytolytic antibody

Indication: Refractory mantle cell lymphoma



4 | P a g e



13. Favipiravir


Mechanism of action: Inhibits RNA-dependent RNA polymerase

Indication: Mild to moderate COVID 19

Dosage Formulation: Film coated tablet

14. n-alkyl dimethyl benzyl ammonium chloride


Mechanism of action: Quaternary ammonium compound with surfactant properties

Indication: Antiseptic agent for hands and inanimate object

Dosage Formulation: 0.105% spray




Coimbatore,Tamilnadu


New drug update

INSIDE THE SERIES

1. Belantamab mafodotin-blmf

2. Nifurtimox

3. Risdiplam

4. Oliceridine

5. Viltolarsen

6. Satralizumab-mwge

7. Ofatumumab

8. Cysteamine hydrochloride

9. Clascoterone

10. Somapacitan-beco

11. Bupivacaine hydrochloride


Department of

Pharmacology,

KMCHIHSR,

Coimbatore,

641014.

Kindly Mail Your

Suggestions To:

hodpharmacology@

kmchihsr.edu.in

1

Series 14

September 2020

1.BELANTAMAB MAFODOTIN- blmfApproval date: August 5, 2020

Mechanism of action: B-cell maturation antigen (BCMA)-directed antibody and

microtubule inhibitor conjugate

Indication: Adult patients with relapsed or refractory multiple myeloma.

Dosage formulation: Lyophilized powder for reconstitution (IV infusion)

2.NIFURTIMOXApproval date: August 6, 2020

Mechanism of action: Nitrofuran antiprotozoal

Indication: Chagas disease (American Trypanosomiasis) in paediatric patients(from

birth to less than 18 years of age and weighing at least 2.5 kg).

Dosage formulation: Tablet

3.RISDIPLAMApproval date: August 7, 2020

Mechanism of action:Survival of motor neuron 2 (SMN2) splicing modifier

Indication: Spinal muscular atrophy (SMA) in patients aged 2 months and older.

Dosage formulation: Powder (Oral solution)

4.OLICERIDINEApproval date: August 7, 2020

Mechanism of action: mu () opioid agonist

Indication: Moderate to severe acute pain in adults

Dosage formulation: Injection (IV)

5.VILTOLARSENApproval date: August 12, 2020

Mechanism of action: An antisense oligonucleotide

Indication: Duchenne muscular dystrophy (DMD) in patients who have a confirmed

mutation of the DMD gene

Dosage formulation: Injection (IV infusion)

2

6.SATRALIZUMAB - mwgeApproval date: August 14, 2020

Mechanism of action: An interleukin-6 (IL-6) receptor antagonist

Indication: Neuromyelitis Optica Spectrum Disorder (NMOSD) in adult patients

who are anti-aquaporin-4 (AQP4) antibody positive.

Dosage formulation: Injection(subcutaneous)

7.CYSTEAMINE HYDROCHLORIDEApproval date: August 19, 2020

Mechanism of action: Cystine-depleting agent

Indication: Corneal cystine crystal deposits in adults and children with cystinosis.

Dosage formulation: Ophthalmic solution

8.OFATUMUMABApproval date: August 20, 2020

Mechanism of action:CD20-directed cytolytic antibody

Indication: Relapsing forms of Multiple Sclerosis (MS) in adults

Dosage formulation: Injection(subcutaneous)

9.CLASCOTERONE

Approval date: August

26, 2020

Mechanism of action:

Androgen receptor

inhibitor

Indication:

Acne vulgaris in patients

aged 12 years and older

Dosage formulation:

Cream

10.SOMAPACITAN

-becoApproval date: August

28, 2020


Human growth hormone

analog

Indication: Adults with

growth hormone

deficiency.

Dosage formulation:

Prefilled Injection

(subcutaneous)

11.BUPIVACAINE

HYDROCHLORIDEApproval date: August

28, 2020


Local anaesthetic

Indication: Post surgical

analgesia up to 24 hours

in adults following open

inguinal hernia repair.

Dosage formulation:

Fully bioresorbable

collagen implant

3Access this series through the KMCH website www.kmchihsr.edu.in

INSIDE STORY:

➢ New drugs

approved by FDA

➢ First in formulation

NEW DRUG UPDATE

Series 15

October 2020

KMCH Institute of Health sciences and Research, Coimbatore

Dept of Pharmacology

Date of approval:

Sep 1, 2020

Mechanism of action: Opioid

agonist

Indication: Severe pain that

requires an opioid analgesic and

for which other treatments are

inadequate

Dosage formulation:

Oral solution

Date of approval:

Sep 1,2020

Mechanism of action: Nucleoside

metabolic inhibitor

Indication: Continued treatment

for adults in first remission with

acute myeloid leukemia

Dosage formulation:

Tablets

Tablets Date of Approval:

Sep 3, 2020


Radioactive diagnostic agent

Indication:

(PET) agent for localization

of somatostatin receptor

positive neuroendocrine

tumors in adult patients

Dosage formulation:

Intravenous Injection

Date of Approval:

Sep 4 2020


Oral selective RET kinase inhibitor

Indication:

Adults with Metastatic RET

Fusion-Positive Non-Small Cell Lung

Cancer

Dosage formulation: Capsules

TRAMADOL HYDROCHLORIDE AZACITIDINE

COPPER Cu 64 DOTATATE PRALSETINIB

We’re on the Web!:

http://www.kmchihsr.edu.in

E-Mail:

[email protected]

Date of Approval:

Sep 29, 2020


Glucocorticoid

Indication: Adrenocortical

insufficiency in infants, children

and adolescents

Dosage formulation:

Immediate release oral granules

Date of Approval:

Oct 14, 2020


Monoclonal antibody combination

Indication: Zaire ebolavirus

infection in adults and children,

including newborns of mothers

who had tested positive for

infection

Dosage formulation:

Intravenous Injection

HYDROCORTISONE

Compiled & Edited by:

Dept of Pharmacology KMCHIHSR Coimbatore. 641014










99, Avanashi Road, Coimbatore-641014, Tamilnadu, INDIA

New Drug Update


INSIDE

THIS ISSUE:

New drugs

approved by

FDA

Atoltivimab, Maftivimab and Odesivimab-ebgn

Date of

Approval

Class of drug Monoclonal antibody

combination Bind to the

glycoprotein, blocking its attachment to cell receptors and preventing entry of the virus into the cells

Indication

Treatment of Zaire Ebola virus infection in adults and children

Newborns of mothers who

have tested positive for the

virus.

Dosage formulation

Injection - administered as a single intravenous infusion

Remdesivir

Date of

Approval

Class of drug

SARS-CoV-2 nucleotide analog

Inhibits RNA-dependent RNA polymerase (RdRp) enzyme complex for genomic replication

Indication

Indicated for the

treatment of COVID-19

patients who require

hospitalization

Dosage formulation

Injection - administered as intravenous infusion once daily for 5-10 days

Series 16

November

2020


Loteprednol etabonate

Date of

Approval

Class of drug

Ophthalmic corticosteroid formulation

Indication

Short-term treatment of the signs and symptoms of Dry eye disease

Dosage formulation

Ophthalmic solution - apply one to two drops four times a day

We’re on the Web!

www.kmchihsr.edu.in

Mail us:

hodpharmacology@kmc

hihsr.edu.in

Compiled &

Edited by Department of Pharmacology KMCHIHSR, Coimbatore. 641014

Mannitol

Date of

Approval

Class of drug

Inhaled dry powder formulation of the sugar alcohol mannitol

Indication

Cystic fibrosis: Indicated as add-on

maintenance therapy to improve pulmonary

function in adult patients

Dosage formulation

Capsules




1 | P a g e N e w D r u g U p d a t e

Compiled & Edited by: Department of Pharmacology, KMCHIHSR, Coimbatore








1. Naxitamab-gqgk

2. Setmelanotide

3. Lumasiran

4. Lonafarnib

5. Sodium sulfate, Magnesium

sulfate, and Potassium chloride

6. Fosphenytoin sodium

Nothing Worth Having

Comes Easy

Series - 17

December 2020


2 | P a g e N e w D r u g U p d a t e

Compiled & Edited by: Department of Pharmacology, KMCHIHSR, Coimbatore


1. Naxitamab-gqgk 2. Setmelanotide

Date of Approval: November 25, 2020

Mechanism of action: GD2-binding

monoclonal antibody

Indication: Refractory neuroblastoma

in combination with GCSF

Dosage Formulation: Intravenous

injection


Mechanism of action: Melanocortin 4

receptor agonist

Indication: Obesity

Dosage Formulation: Subcutaneous

injection

3. Lumasiran 4. Lonafarnib


Mechanism of action: Degradation of

Hydroxy acid oxidase 1 messenger RNA

Indication: Primary Hyperoxaluria

Type 1

Dosage Formulation: Subcutaneous

injection



Farnesyltransferase inhibitor

Indication: Hutchinson-Gilford Progeria

Syndrome and Progeroid Laminopathies

Dosage Formulation: Capsule

5. Sodium sulfate, Magnesium

sulfate and Potassium chloride 6. Fosphenytoin sodium


Mechanism of action: Osmotic laxative

Indication: To cleanse the colon before

a colonoscopy

Dosage Formulation: Tablet


Mechanism of action: Prodrug of

phenytoin, blocks voltage-dependent

membrane sodium channels

Indication: Status epilepticus, seizures

occur during neurosurgery


(Room temperature stable)


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