This is my 22nd ppt............................ It contains HALF of the totl drugs approved by US-FDA for 2014 Consists of 20 drugs...out of 41 Do go through it.....and send ur reviews! Regards, Rxvichu-alwz4uh! :)

1. PRESENTED BY:
VISHNU.R.NAIR,
4TH YEAR PHARM.D,
NATIONAL COLLEGE OF PHARMACY(NCP)

2.  INNOVATION drives PROGRESS
 As far as INNOVATION regarding development of new drugs & therapeutic
biological products is concerned, FDA’S CENTER FOR DRUG EVALUATION &
RESEARCH(CDER) supports the pharmaceutical industry at every step of the
process
 With its understanding of the science used to create new products, testing &
manufacturing procedures, along with the diseases & conditions, that new
products are designed to treat, FDA provides SCIENTIFIC & REGULATORY
ADVICE, required to bring new therapies to market
 Thus, I am going to present 20(out of 41) NEWER DRUGS APPROVED BY US-
FDA for the year 2014……………………………………………………

3. NEWER DRUGS APPROVED
BY US-FDA FOR
2014……………………………
………………

4. 1. DAPAGLIFLOZIN(FARXIGA):
i. CLASS : ANTI-DIABETICS; SGLT-2 INHIBITORS
ii. APPROVED ON: 8/1/2014
iii. INDICATION: To improve GLYCEMIC CONTROL, along with diet & exercise,
in adults with TYPE-II DIABETES MELLITUS
iv. MOA:
- SGLT-2(Sodium glucose transporter-2)  present in PCT  Responsible for
MAXIMUM REABSORPTION of GLUCOSE from tubular lumen  Harmful for
DM patients
- Drug  BLOCKS SGLT-2  REDUCES GLUCOSE REABSORPTION 
REDUCES RENAL THRESHOLD FOR GLUCOSE  REDUCES URINARY
GLUCOSE EXCRETION
v. ADRs:
- RENAL IMPAIRMENT (>10%)
- UTI (4.3-5.7%)
- DYSLIPIDAEMIA (2.1-2.5%)

5. vi. DRUG INTERACTION:
- DRUG + CHLORPROPAMIDE  Increased risk of HYPOGLYCEMIA
vii. CONTRAINDICATIONS:
- GFR < 30 ml/min/1.73 meter sq.
- ESRD
- Patients , on DIALYSIS
viii. DOSE:
- INITIAL DOSE: 5 mg PO every day, in morning, with/ without food
- Increase dose to 10 mg PO every day(if GFR > 60 ml/min)…………..

6. 2. TASIMELTEON(HETLIOZ):
i. APPROVED ON : 31/01/2014
ii. CLASS : SEDATIVE/ HYPNOTICS; MELATONIN RECEPTOR AGONISTS
iii. INDICATION : To treat NON-24 –HOUR SLEEP-WAKE DISORDER, in
TOTALLY BLIND INDIVIDUALS
iv. MOA:
- NON-24 : “CHRONIC, CIRCADIAN RHYTHM(body clock) disorder(in the blind);
associated with PROBLEMS in SLEEP TIMINGS”
- Daily exposure to LIGHT-DARK CYCLE  SYNCHRONIZES CIRCADIAN
CLOCK , with the 24-hour day
- Absence of light perception SLEEP-WAKE CYCLES SHIFT 
DESYNCHRONIZATION of CIRCADIAN CLOCK OCCURS
- DRUG  binds, with HIGH AFFINITY to MT-1 & MT-2 receptors in
SUPRACHIASMATIC NUCLEUS of BRAIN  Causes SYNCHRONIZATION of
body’s MT & CORTISOL CIRCADIAN RHYTHMS  Alleviates NON-24 HOUR
DISORDER

7. v. ADRs:
- Headache (10%)
- Increased ALT levels (10%)
- Nightmares/ abnormal dreams (10%)
vi. INTERACTION:
- DRUG + FENTANYL  Increased risk of SEDATION, RESPIRATORY
DEPRESSION & COMA
vii. DOSE:
- 20 mg PO, every day, before bedtime, at the SAME TIME EVERY
NIGHT…………………

8. 3. ELOSULFASE ALFA(VIMIZIM):
i. APPROVED ON: 14/02/2014
ii. INDICATION: To treat MUCOPOLYSACCHARIDOSIS TYPE “IV A”(MORQUIO ‘A’
SYNDROME)
iii. CLASS : ENZYMES, METABOLIC
iv. MOA:
- MORQUIO ‘A’ SYNDROME is a RARE, INHERITED DISORDER, that affects major
organ systems in the body
- Disease is a form of MUCOPOLYSACCHARIDOSIS, which is a type of LYSOSOME
STORAGE DISEASE
- People born with MORQUIO ‘A’  Can’t break down GAG(Glycosaminoglycans)
molecules, due to DEFICIENCY of N-ACETYL, GALACTOSAMINE-6-SULFATASE
(GALNS)
- GALNS Breaks down/ recycles materials that the body CAN’T USE
- Enzyme deficiency INCREASES ACCUMULATION of GAG SUBSTRATES (KERATIN
SULFATE (KS); CHONDROITIN SULFATE (C6S)) in LYSOSOMAL compartment of cells
 causes WIDESPREAD ORGAN DYSFUNCTION

9. - DRUG  Provides EXOGENOUS ENZYME GALNS  GALNS is taken up into
LYSOSOMES  Increases CATABOLISM of KS & C6S
v. ADRs:
- Pyrexia (33%)
- Headache (31%)
- Abdominal pain (21%)
vi. DOSE:
2 mg/kg i.v, infused for 3.5-4.5 hours………………………………….

10. A PERSON, AFFECTED BY MORQUIO ‘A’
SYNDROME

11. 4. DROXIDOPA (NORTHERA):
i. APPROVED ON: 18/02.2014
ii. INDICATION : To treat NEUROGENIC ORTHOSTATIC HYPOTENSION
(NOH)
iii. CLASS : ALPHA & BETA-ADRENERGIC AGONIST
iv. MOA:
- NOH is a sign of CARDIOVASCULAR AUTONOMIC DYSFUNCTION, that is
caused by FAILURE of NORADRENERGIC NEUROTRANSMISSION, caused
by AUTONOMIC DYSREGULATION
- Associated with sustained fall of(within 3 minutes of standing):
• SYSTOLIC B.P by 20 mm Hg
• DIASTOLIC B.P by 10 mm Hg
- DRUG  NOREPINEPHRINE PRECURSOR  Metabolized by DOPA-
DECARBOXYLASE to NE  distributed throughout body  raises SYSTOLIC &
DIASTOLIC B.P

12. v. ADRs:
a. Headache (13.2%)
b. Dizziness (9.6%)
c. HTN (7%)
vi. CONTRAINDICATION:
a. Hypersensitivity
vii. DRUG INTERACTION :
a. DRUG + AMPHETAMINE  PHARMACODYNAMIC SYNERGISM  Raises
BP & HR
viii. DOSE: 100 mg TID ;P.O…………………………………..

13. 5. METRELEPTIN FOR INJECTION(MYALEPT):
i. CLASS : LEPTIN ANALOGUE
ii. APPROVED ON : 24.02.2014
iii. INDICATION: To treat COMPLICATIONS of LEPTIN DEFICIENCY
iv. MOA:
- LEPTIN is a hormone, secreted by ADIPOSE TISSUE
- LEPTIN  informs CNS of status of ENERGY STORES in body
- Deficiency of ADIPOSE TISSUE Causes LEPTIN DEFICIENCY  Causes
LIPODYSTROPHY, HYPERTRIGLYCERIDEMIA, & FAT DEPOSITION in non-
adipose tissues (liver, muscle)  causes metabolic abnormalities, including
insulin resistance
- DRUG  RECOMBINANT ANALOG of hormone LEPTIN
- DRUG  binds to human LEPTIN RECEPTOR  Activates it  alleviates
LIPODYSTROPHY MANIFESTATIONS.

14. - ADRs:
a. Headache (13%)
b. Hypoglycemia (13%)
c. Reduced weight (13%)
- DRUG INTERACTION:
a. DRUG + CHLORPROPAMIDE  increased risk of HYPOGLYCEMIA
- CONTRAINDICATION:
a. Hypersensitivity
- DOSE :
a. For males/females <40 kg weight : 0.06 mg/kg s.c
b. For males > 40 kg : 2.5 mg s.c
c. For females > 40 kg : 5 mg s.c……………………………..

15. 6. FLORBETABEN F-18 INJECTION
(NEURACEQ):
i. CLASS : DIAGNOSTIC IMAGING AGENTS
ii. APPROVED ON : 19.03.2014
iii. INDICATION : For PET imaging of brain
iv. MOA:
- Agent  binds to BETA-AMYLOID PLAQUES in brain  produces POSITRON
SIGNAL  Detected by PET SCANNER
v. ADRs:
- Injection site pain (3.9%)
- Injection site erythema (1.7%)
vi. DOSE:
300 mBq, by slow i.v bolus………………………………………

16. 7. MILTEFOSINE (IMPAVIDO):
i. CLASS : ANTI-LEISHMANIASIS AGENTS
ii. APPROVED ON: 19.3.2014
iii. INDICATION: To treat a tropical disease called LEISHMANIASIS
iv. MOA:
- LEISHMANIASIS is a disease, caused by PROTOZOAN PARASITES of GENUS
LEISHMANIA
- Spread by bites of SANDFLIES (Female PHLEBOTOMINE)
- Causatives include:
a. L. donovani
b. L. infantum
c. L. chagasi, etc

17. - Drug  interacts with MEMBRANE LIPIDS, PHOSPHOLIPIDS & STEROLS of
LEISHMANIA species  inhibits CYTOCHROME ‘C’ OXIDASE found in
MITOCHONDRIA  causes APOPTOSIS-LIKE CELL
DEATH……………………..
v. ADRs:
- Increased transaminase levels (94%)
- Reduced platelet counts (62%)
- Motion sickness (29.2%)
vi. CONTRAINDICATIONS:
- Pregnancy
- Hypersensitivity
- SJOGREN-LARSSON SYNDROME ( Condition, characterized by DRY, SCALY
SKIN[ICHTHYOSIS]; NEUROLOGICAL PROBLEMS; & EYE PROBLEMS)
vii. DOSE:
- For weight > 45 kg : 50 mg PO, TID, for 4 weeks
- For weight < 45 kg : 50 mg PO, BID, for 4 weeks………………………………

18. A PERSON, AFFECTED WITH SJOGREN-LARSSON
SYNDROME

19. 8. APREMILAST (OTEZLA):
i. CLASS : DMARD; PDE-4 INHIBITORS
ii. APPROVED ON : 21.03.2014
iii. INDICATION : To treat adults with ACTIVE PSORIATIC ARTHRITIS
iv. MOA:
- PSORIATIC ARTHRITIS is a type of INFLAMMATORY ARTHRITIS, found in
people with PSORIASIS
- Associated with PAIN, SWELLING & STIFFNESS in 1/ more joints
- DRUG  INHIBITS PDE-4  Increases CYCLIC-AMP Levels  Alleviates
PSORIATIC ARTHRITIS
v. ADRs:
- Diarrhea (7.7-9.3%)
- Nausea (7.4-8.9%)
- Headache (4.8-5.9%)

20. vi. INTERACTION:
- DRUG + CBZ  Reduces drug levels and effects
vii. CONTRAINDICATION:
- Hypersensitivity
viii. DOSE :
- DAY 1 : 10 mg in AM
- DAY 2 : 10 mg in AM & PM
- DAY 3 : 10 mg in AM , & 20 mg in PM
- DAY 4 : 20 mg in AM & PM
- DAY 5 : 20 mg in AM & 30 mg in PM
- DAY 6 , and thereafter : 30 mg PO BID………………………………………

21. 9. ALBIGLUTIDE(TANZEUM):
i. APPROVED ON : 15.04.2014
ii. INDICATION : To improve GLYCEMIC CONTROL, along with diet in
exercise, in adults, with type II DM
iii. CLASS : ANTIDIABETICS; GLP-1 AGONISTS
iv. MOA:
- DRUG  Agonizes GLP-1 RECEPTOR  increases GLUCOSE-DEPENDANT
INSULIN SECRETION
v. ADRs:
- URTI (13%)
- Diarrhea (10.5%)
vi. INTERACTION :
- DRUG + ARIPIPRAZOLE  ANTAGONISTIC EFFECT

22. vii. CONTRAINDICATIONS:
a. Hypersensitivity
b. Personal/family history of MEDULLARY THYROID CARCINOMA
c. MULTIPLE ENDOCRINE NEOPLASIA TYPE-II(MEN-II)
viii. DOSE:
30 mg s.c; once weekly increase to 50 mg once weekly(if glycemic control is not
established)………………………….

23. 10. RAMUCIRUMAB (CYRAMZA):
i. APPROVED ON : 21.04.2014
ii. INDICATION : To treat patients with ADVANCED STOMACH CANCER /
GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA
iii. CLASS : ANTINEOPLASTICS; VEGF-INHIBITOR
iv. MOA:
- DRUG  specifically binds to VEGF RECEPTOR TYPE 2  Blocks binding of
VEGFR ligands (VEGF-A; VEGF-C; VEGF-D) inhibition of LIGAND-
STIMULATED ACTIVATION of VEGF-2  Inhibits PROLIFERATION &
MIGRATION of ENDOTHELIAL CELLS
v. ADRs:
- Fatigue (57%)
- Neutropenia (54%)
- Stomatitis (37%)

24. vi. DOSE:
a. For NON- SMALL CELL LUNG CANCER (NSCLC)  10 mg/kg i.v; infused
over 1 hour prior to DOCETAXEL (75 mg/meter sq.) infusion on DAY 1 of a 21-
day cycle
b. For GASTRIC CANCER : 8 mg/kg i.v every 2 weeks; infused over 1 hour; along
with PACLITAXEL (80 mg/meter sq.) ………………………….

25. 11. SILTUXIMAB(SYLVANT):
i. APPROVED ON: 23.04.2014
ii. INDICATION : To treat patients with MULTICENTRIC CASTLEMAN’S
DISEASE(MCD)
iii. CLASS : IMMUNOMODULATORS; ANTINEOPLASTICS; MONOCLONAL
ANTIBODY
iv. MOA:
- MCD is a LYMPHOPROLIFERATIVE DISORDER that involves
HYPERACTIVATION of the immune system, excessive release of CYTOKINES,
proliferation of B & T CELLS and MULTIPLE ORGAN SYSTEM
DYSFUNCTION
- May be localized to a SINGLE LYMPH NODE/ MULTIPLE
- Associated with LYMPH NODE HYPERPLASIA, AUTOIMMUNE DISORDERS,
& MALIGNANCIES
- Also known as LYMPHOID HAMARTOMA, ANGIOFOLLICULAR LYMPH
NODE HYPERPLASIA , etc.

26. - DRUG is an IL-6 blocker
- DRUG  binds to IL-6  Prevents binding of IL-6 to its receptors  alleviates
symptoms of CASTLEMAN’S DISEASE
v. ADRs:
- Pruritus (28%)
- Hyperuricemia (11%)
- Thrombocytopenia (9%)
vi. INTERACTION:
- DRUG + CHOLERA VACCINE Increases risk of INFECTION, by
IMMUNOSUPPRESSIVE EFFECTS
vii. CONTRAINDICATION :
- Severe hypersensitivity
viii. DOSE:
11 mg/kg i.v every 3 weeks; infused for 1 hour……………………..

27. 12. CERITINIB(ZYKADIA):
i. APPROVED ON: 29.4.2014
ii. INDICATION : To treat patients, with LATE-STAGE (METASTATIC) NSCLC
iii. CLASS :ANTINEOPLASTICS; ANAPLASTIC LYMPHOMA KINASE
INHIBITOR
iv. MOA:
- NSCLC is any type of EPITHELIAL LUNG CANCER, other than SMALL CELL
LUNG CARCINOMA (SCLC)
- Usually INSENSITIVE to CHEMOTHERAPY, and treated with SURGERY
- Types include SQUAMOUS CELL CARCINOMA; LARGE CELL CARCINOMA;
& ADENOCARCINOMA
- DRUG is a TYROSINE KINASE INHIBITOR
- DRUG  Binds to ALK(ANAPLASTIC LYMPHOMA KINASE)  inhibits
AUTOPHOSPHORYLATION & ALK-MEDIATED PHOSPHORYLATION
required for PROLIFERATION of ALK-DEPENDANT CANCER CELLS

28. v. ADRs:
- Diarrhea (86%)
- Reduced hemoglobin (84%)
- Increased ALT & AST (80%)
vi. INTERACTION:
DRUG + FLIBANSERIN  Severe HYPOTENSION/ SYNCOPE
vii. DOSE:
750 mg PO every day……………………..

29. 13. VORAPAXAR(ZONTIVITY):
i. APPROVED ON : 08.05.2014
ii. INDICATION : To reduce the risk of STROKE & HEART ATTACKS in HIGH-
RISK PATIENTS
iii. CLASS : ANTIPLATELET AGENTS; CARDIOVASCULAR; PROTEASE
ACTIVATED RECEPTOR-1 (PAR-1) INHIBITORS ; THROMBIN
INHIBITORS
iv. MOA:
- DRUG  Reversibly blocks PAR-1 RECEPTOR (expressed on PLATELETS)
- DRUG  inhibits THROMBIN RECEPTOR AGONIST PEPTIDE (TRAP)-
induced PLATELET AGGREGATION
v. ADRs:
- Anemia (5%)
- Depression (2.4%)

30. vi. INTERACTION:
DRUG + DEFIBROTIDE  PHARMACODYNAMIC SYNERGISM
vii. CONTRAINDICATION:
- Active pathological bleeding
viii. DOSE : 2.08 mg PO every day (in combination with ASPIRIN/
CLOPIDOGREL)…………….

31. 14. VEDOLIZUMAB(ENTYVIO):
i. APPROVED ON : 20.05.2014
ii. INDICATION : To treat adult patients with moderate-severe ULCERATIVE
COLITIS & CROHN’S DISEASE
iii. CLASS: IBD AGENTS; MONOCLONAL ANTIBODIES; INTEGRIN
BLOCKERS
iv. MOA:
- DRUG  Recombinant humanized monoclonal antibody
- DRUG  binds specifically to ALPHA-4;BETA-7 INTEGRIN  Blocks
interaction of above INTEGRIN with MAdCAM-1(Mucosal adhesion addressin
cell adhesion molecule)  inhibits migration of MEMORY-T-LYMPHOCYTES
across endothelium , into inflamed gastrointestinal parenchymal tissue
v. ADRs:
- Nasopharyngitis (13%)
- Headache (12%)

32. vi. INTERACTION:
DRUG + ADALIMUMAB  increased IMMUNOSUPPRESSIVE EFFECTS 
increased risk of INFECTIONS
vii. CONTRAINDICATION:
- Hypersensitivity
viii. DOSE:
a. Initially  300 mg i.v at weeks 0,2,6
b. Maintenance dose : 300 mg i.v ; every 8 weeks…………………..

33. 15. DALBAVANCIN (DALVANCE):
i. APPROVED ON : 23.05.2014
ii. INDICATION : To treat adults with skin infections
iii. CLASS : GLYCOPEPTIDE ANTIBIOTICS
iv. MOA:
- DRUG  Binds to D-ALANYL-D-ALANINE TERMINUS of PENTAPEPTIDE in
cell wall PEPTIDOGLYCAN of susceptible organism  prevents CROSS-
LINKING  Interferes with CELL-WALL SYNTHESIS  BACTERICIDAL
EFFECT
- Usually BACTERICIDAL against STAPHYLOCOCCUS AUREUS &
STREPTOCOCCUS PYOGENES
v. ADRs:
- Nausea (5.5%)
- Eosinophilia (<2%)
- Hematochezia (<2%)

34. vi. CONTRAINDICATION:
- Hypersensitivity
vii. DOSE:
- 1500 mg i.v; infused over 30 minutes…………………………

35. 16. EFINACONAZOLE(JUBLIA):
i. APPROVED ON: 06.06.2014
ii. INDICATION : To treat mild-moderate ONYCHOMYCOSIS
iii. CLASS : TOPICAL ANTIFUNGALS; TRIAZOLES
iv. MOA:
- ONYCHOMYCOSIS, also known as TINEA UNGUIUM, is a fungal infection of
the NAIL
- Mainly TOENAILS are affected
- DRUG  inhibits FUNGAL LANOSTEROL 14-ALPHA DEMETHYLASE 
inhibits synthesis of ERGOSTEROL  cell membrane integrity lost  cell death
v. ADRs:
- Application site dermatitis (2.2%)
- Application site pain (1.1%)

36. vi. DOSE:
For TRICHOPHYTON RUBRUM & TRICHOPHYTON MENTAGROPHYTES
infection : 10% topical solution…………………

37. A PERSON, AFFECTED WITH ONYCHOMYCOSIS

38. 17. TEDIZOLID PHOSPHATE (SIVEXTRO):
i. APPROVED ON : 20.06.2014
ii. INDICATION: To treat adults with SKIN INFECTIONS
iii. CLASS : OXAZOLIDINONE ANTIBIOTICS
iv. MOA:
- DRUG  Binds to 50S subunit of bacterial RIBOSOME  Causes inhibition of
PROTEIN SYNTHESIS
v. ADRs:
- Hemoglobin< 10.1 mg/dl (3.1%)
- Reduced platelet count (2.3%)
- Palpitations (<2%)
vi. DOSE :
200 mg PO/ i.v every day; for 6 days…………………….

39. 18. TAVABOROLE (KERYDIN):
i. APPROVED ON : 07.07.2014
ii. INDICATION : For the topical treatment of ONYCHOMYCOSIS of the
TOENAILS
iii. CLASS : TOPICAL ANTIFUNGALS; OXABOROLE DERIVATIVE
iv. MOA:
- DRUG  inhibits AMINOACYL- t-RNA SYTHETASE (AARS) inhibits
PROTEIN SYNTHESIS
v. ADRs:
- Application site exfoliation (2.7%)
- Application site erythema (1.6%)
vi. DOSE :
0.5% topical solution(apply to affected toenails daily for 48 weeks)………………..

40. 19. EMPAGLIFLOZIN (JARDIANCE) :
i. APPROVED ON : 01.08.2014
ii. INDICATION : To improve glycemic control in adults with TYPE II DM
iii. CLASS : ANTI-DIABETICS; SGLT-2 INHIBITORS
iv. MOA:
- DRUG  Blocks SGLT-2  reduces GLUCOSE REABSORPTION  Reduces
RENAL THRESHOLD for glucose  reduces URINARY GLUCOSE
EXCRETION
v. ADRs:
- UTI (7.6-9.3%)
- Increased urination (3.2-3.4%)
- URTI (5.4-6.4%)
vi. INTERACTION:
DRUG + AMILORIDE  PH. SYNERGISM  increased URINE VOLUME 
Increased risk of VOLUME DEPLETION…………….

41. vii. CONTRAINDICATIONS:
- Hypersensitivity
- ESRD
- Patients on DIALYSIS
viii. DOSE:
- 10 mg PO every day, in the morning, taken with/ without food………………….

42. 20. ORITAVANCIN (ORBACTIV):
i. APPROVED ON : 06.08.2014
ii. INDICATION : To treat adults with SKIN INFECTIONS
iii. CLASS : GLYCOPEPTIDE ANTIBIOTICS
iv. MOA:
- Shows 3 actions:
a. DRUG  binds to PEPTIDOGLYCAN RESIDUES  Inhibits
POLYMERIZATION step of cell wall biosynthesis
b. DRUG  Binds to PEPTIDE-BRIDGING SEGMENTS OF CELL WALL 
Inhibits TRANSPEPTIDATION(CROSS-LINKING) STEP OF CELL WALL
BIOSYNTHESIS
c. DRUG  disrupts BACTERIAL MEMBRANE INTEGRITY  causes
DEPOLARIZATION, INCREASED MEMBRANE PERMEABILITY & CELL
DEATH

43. v. ADRs:
- Infusion site phlebitis (2.5%)
- Increased ALT (2.8%)
- Headache (7.1%)
vi. INTERACTION :
DRUG + CHOLERA VACCINE  PHARMACODYNAMIC ANTAGONISM
vii. CONTRAINDICATION:
Hypersensitivity
viii. DOSE:
1200 mg i.v, given over 3 hours……………………………………

44.  www.fda.gov.in
 www.drugs.com
 www.drugbank.com
 www.rxlist.com
 www.webmd.com

45. THANK YOU !!!!!
  