This document summarizes 19 drugs approved by the FDA in 2014. It provides the drug name, company, approved indication, and molecular mechanism of action for each drug in 1-2 sentences. The drugs cover a wide range of therapeutic areas and include small molecule drugs, biologics, and vaccines.

1. Presented By Facilitated By
ALBIN JOSE.V DR. SHIVALINGE GOWDA K.P.
M.Pharm- I H.O.D & Associate Professor
Dept.Of Pharmacology Dept.Of Pharmacology
PESCP PESCP
4/16/20151
EVALUATION SEMINAR ON
MOLECULAR MECHANISMS OF FDA APPROVED
DRUGS IN 2014

2. FDA APPROVED DRUGS IN 2014
4/16/20152
1. Dyloject - Diclofenac sodium Injection
2.Namzaric - Donepezil and memantine
3.Saxenda - Liraglutide Injection
4.Opdivo - Nivolumab Injection
5.Rapivab - Peramivir Injection
6.Zerbaxa - Ceftolozane and tazobactam Injection
7.Lynparza - Olaparib Capsules
8.Viekira Pak - Ombitasvir/Paritaprevir/Ritonavir with Dasabuvir Tablets
9.Xtoro -Finafloxacin Otic Suspension
10.Signifor LAR - Pasireotide for Injectable Suspension

3. 4/16/20153
11.Gardasil 9 - Human papillomavirus 9-valent vaccine,
recombinant Injection
12.Blincyto - Blinatumomab Injection
13.Kitabis Pak - Tobramycin Inhalation Solution
14.Onexton - Benzoyl peroxide and clindamycin phosphate
Gel
15.Hysingla ER - Hydrocodone bitartrate Extended-Release
Tablets
16.Lemtrada - Alemtuzumab Injection
17.Xigduo XR - Dapagliflozin and metformin hydrochloride
Extended-Release Tablets
18.Trumenba - Meningococcal group B vaccine
19.Obizur -Antihemophilic factor (recombinant)

4. 4/16/20154
1. Dyloject -Diclofenac sodium Injection
Company: Javelin Pharmaceuticals, Inc.
Approved indication: Pain
Diclofenac sodium injection
 It is an intravenous non-steroidal anti-inflammatory drug (NSAID)
for the management of acute moderate-to-severe pain in adults.
Molecular Mechanism
1. Inhibition of prostaglandin synthesis by inhibition
of cyclooxygenase (COX)

5. 4/16/20155
2. Namzaric -Donepezil and Memantine
Company: Actavis plc and Adamas Pharmaceuticals Inc.
Approved indication : Alzheimer's Disease
Molecular Mechanism
1. Memantine hydrochloride - NMDA receptor antagonist
2. Donepezil hydrochloride -acetylcholinesterase inhibitor.
3. Saxenda -Liraglutide Injection
Company: Novo Nordisk Inc.
Approved indication : Obesity
Liraglutide is a once-daily dose
 Glucagon- peptide-1 (GLP-1) analogue for the treatment of
obesity.

6. 4/16/20156
4. Opdivo - Nivolumab Injection
Company: Bristol-Myers Squibb Company
Approved indication: Melanoma – Metastatic
 Nivolumab is a programmed death receptor-1 (PD-1) blocking
antibody for the treatment of advanced melanoma.
Molecular mechanism
 Human IgG4 PD-1 immune checkpoint inhibitor “Nivolumab for
treatment of malignant melanoma.
5. Rapivab -Peramivir Injection
Company: BioCryst Pharmaceuticals, Inc.
Approved indication: Influenza
 Peramivir is an influenza virus neuraminidase inhibitor
 Indicated for the treatment of acute uncomplicated influenza in
adults.

7. 4/16/20157
Mechanism of Action:
 Peramivir is a cyclopentane analogue
 It competitively binds to the active site of the influenza virus neuraminidase.
 Peramivir inhibits the neuraminidase activity of several strains of influenza A and
B viruses, including H1N1 influenza A (swine influenza).
6. Zebra -Ceftolozane and Tazobactam Injection
Company: Cubist Pharmaceuticals, Inc.
Approved indication: Intraabdominal Infection, Urinary Tract Infection
 Ceftolozane and Tazobactam is a cephalosporin and beta-lactamase inhibitor
combination for the treatment of complicated intra-abdominal infections (cIAI)
and complicated urinary tract infections (cUTI).
Molecular mechanism
 Ceftolozane-Inhibit the cell wall synthesis.
 Tazobactum-Beta-lactamase inhibitor.

8. 4/16/20158
7.Lynparza-Olaparib Capsules
Company: AstraZeneca
Approved indication: Ovarian Cancer
Mechanism of Action:
 Poly adenosine 5’-diphospho ribose polymerase (PARP)
family inhibitor PARP-1 PARP- 2 PARP-3.
8. Viekira Pak -Ombitasvir/Paritaprevir/Ritonavir with
Dasabuvir Tablets
Company: AbbVie Inc.
Approved indication: Chronic Hepatitis C
 Viekira Pak for the treatment of patients with genotype 1
chronic hepatitis C virus (HCV) infection.

9. 4/16/20159
Mechanism of action
Ombitasvir - NS5A inhibitor with potent pangenotypic picomolar antiviral
activity
Paritaprevir - Inhibitor of the NS3/4A serine protease
Ritonavir – Potent inhibitor of CYP3A4 enzymes
Dasabuvir - Nonnucleoside NS5B polymerase inhibitor and also used for
pharmacologic booster paritaprevir
9. Soolantra -Ivermectin Cream
Company: Galderma Laboratories, L.P.
Approved indication: Acne Rosacea
 Lvermectin is a topical antiparasitic with anti-inflammatory properties for the
treatment of rosacea potentially caused by the microscopic skin
mite Demodex folliculorum.
Molecular mechanism
 Anthelmintic drug- Inhibiting neuronal activity and muscular contractility in
arthropods and nematodes
 By activating glutamate-gated chloride channels (GluClRs) at nanomolar
concentrations

10. 4/16/201510
10.Xtoro -Finafloxacin Otic Suspension
Company: Alcon Laboratories, Inc.
Approved indication : Otitis Externa
Finafloxacin Otic suspension is a fluoroquinolone
antimicrobial for the treatment of acute otitis externa,
commonly known as swimmer’s ear.
Molecular mechanism
Quinolones-Inhibit the enzyme bacterial DNA gyrase.
11.Signifor LAR -Pasireotide for Injectable Suspension
Company: Novartis
Approved indication: Acromegaly
Pasireotide is a long acting a somatostatin analog
formulation for the treatment of patients with acromegaly.

11. 4/16/201511
Molecular mechanism
1. Pasireotide activates somatostatin receptors,
exhibiting a much higher binding affinity for
Somatostatin receptors 1, 3, and 5 than octreotide in
vitro, as well as a comparable binding
affinity for somatostatin receptor
2. The binding and activation of the somatostatin
receptors causes inhibition of ACTH secretion
and results in reduced cortisol secretion in
Cushing's disease patients. Also this agent is more
potent than somatostatin in inhibiting the release of
human growth hormone (HGH),
glucagon, and insulin.

12. 12.Gardasil 9 -Human papillomavirus 9-valent vaccine,
recombinant Injection
Company: Merck & Co., Inc.
Approved indication: Human Papillomavirus Prophylaxis
Human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV
vaccine for the prevention of cervical, vulvar, vaginal, and anal cancers
caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.
13.Blincyto -Blinatumomab Injection
Company: Amgen Inc.
Approved indication: Acute Lymphoblastic Leukemia
Blinatumomab is a bispecific CD19-directed CD3 T-cell engager
indicated for the treatment of Philadelphia chromosome-negative
relapsed or refractory B-cell precursor acute lymphoblastic leukemia
(ALL). 4/16/201512

13. 4/16/201513
Molecular mechanism
 A molecule of Blinatumomab combines two binding sites:
 CD3 site for T cells and CD19 site for the target B cells.
 CD3 is part of the T cell receptor.
 The drug works by linking these two cell types
activating the T cell to exert cytotoxic activity on the target cell.
14.Kitabis Pak -Tobramycin Inhalation Solution
Company: PulmoFlow, Inc.
Approved indication: Cystic Fibrosis
Tobramycin is an aminoglycoside inhalation solution co-
packaged with a PARI LC PLUS® Reusable Nebulizer for the
management of cystic fibrosis.

14. 4/16/201514
Molecular mechanism
Tobramycin binding to a site on the
bacterial 30S and 50S ribosome,
preventing formation of the 70S complex.
As a result, mRNA cannot be translated into protein and
cell death .
15.Onexton-Benzoyl peroxide and Clindamycin
phosphate Gel
Company: Valeant Pharmaceuticals International,
Inc.
Approved indication: Acne
Benzoyl peroxide and Clindamycin phosphate is an
antimicrobial and lincosamide antibacterial combination
for the once-daily topical treatment of acne vulgaris

15. 4/16/201515
Molecular mechanism
Clindamycin: It is a lincosamide antibacterial.
Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent
with bacteriocidal and keratolytic effects, but the precise
mechanism of action is unknown.
16.Hysingla ER-Hydrocodone bitartrate Extended-
Release Tablets
Company: Purdue Pharma L.P.
Approved indication: Chronic Pain
Hydrocodone is a single-entity (without acetaminophen)
extended-release opioid analgesic for around-the-clock
management of moderate to severe chronic pain.

16. 4/16/201516
Molecular mechanism
 As a narcotic, Hydrocodone relieves pain by binding to Opioid receptors in
the CNS.
 It acts primarily on μ-opioid receptors, with about six times lesser affinity to
δ-opioid receptors.
 In blood, 20–50% of hydrocodone is bound to protein.
17.Lemtrada-Alemtuzumab Injection
Company: Genzyme
Approved indication: Multiple Sclerosis
 Alemtuzumab is a CD52-directed cytolytic monoclonal antibody indicated for
the treatment of relapsing forms of multiple sclerosis (MS).
Molecular mechanism
 Alemtuzumab is a humanized mAb, which targets the surface molecule
CD52 on all T cell populations and other cellular components of the
immune system such as thymocytes, B cells, and monocytes.
 Alemtuzumab, which is administered intravenously, depletes T as well as B
lymphocyte populations for extended periods.
Adverse effects in MS patients such as thyroid disorders and
idiopathic thrombocytopenic purpura.

17. 4/16/201517
18.Xigduo XR -Dapagliflozin and Metformin
hydrochloride Extended-Release Tablets
Company: AstraZeneca
Approved indication: Diabetes Type 2
 Xigduo XR (Dapagliflozin and Metformin
hydrochloride)
 It is a once-daily sodium-glucose cotransporter 2
(SGLT2) inhibitor and biguanide combination for the
treatment of type 2 diabetes.

18. 4/16/201518
Molecular mechanism
Dapagliflozin –
 Inhibits subtype 2 of the sodium-glucose transport proteins (SGLT2)
 which are responsible for at least 90% of the
glucose reabsorption in the kidney.
 Blocking this transporter mechanism causes blood glucose to be
eliminated through the urine.
Metformin
 Metformin decreases hyperglycemia primarily by suppressing
glucose production by the liver (hepatic gluconeogenesis).
19.Trumenba -meningococcal group B vaccine
Company: Pfizer Inc.
Approved indication: Meningococcal Meningitis Prophylaxis
 Trumenba (Meningococcal group B vaccine) is indicated for active
immunization to prevent invasive disease caused by Neisseria
meningitidis serogroup B in adolescents and young adults.