MARCH-APRIL-MAY 2015 US-FDA APPROVED DRUGS

                             MARCH-APRIL-MAY 2015 US-FDA APPROVED DRUGS

                                          MARCH 2015 US-FDA APPROVED DRUGS

1. TRADE (BRAND) NAME- Cresemba
ACTIVE PHARMACEUTICAL INGREDIENT- Isavuconazonium sulfate
COMPANY NAME- Astellas
USE- Isavuconazonium sulfate is a prodrug of 'isavuconazole' which is a triazole anti-fungal drug. It inhibits lanosterol 14-alpha demethylase-an enzyme which is responsible for the conversion of lanosterol to ergosterol- the building block for fungal cell walls. It is approved for the treatment of invasive aspergillosis (a fungal infection which mostly affects lungs and usually occurs with patients with tuberculosis and chronic obstructive pulmonary disorders-COPD) and invasive mucormycosis (a fungal infection mainly affecting the lungs, sinuses and brain).

                                                   ISAVUCONAZONIUM SULFATE

2. TRADE (BRAND) NAME- Cholbam
ACTIVE PHARMACEUTICAL INGREDIENT- Cholic acid
COMPANY NAME- Asklepion Pharmaceuticals
USE- Cholic acid is one of the major bile acids which is produced in the liver of human body from cholesterol. It decreases the effectiveness or downregulation of cholesterol-7-alpha hydrolase - a rate limiting step of bile acid synthesis. Cholbam capsules are approved for the treatment of bile acid synthesis disorders as well as peroxisomal disorders.

                                                               CHOLIC ACID   
                      
3. TRADE (BRAND) NAME- Opdivo
ACTIVE PHARMACEUTICAL INGREDIENT- Nivolumab
COMPANY NAME- Bristol-Myers Squibb
USE- Nivolumab is a humanized whole IgG 4 anti- PD 1 (programmed cell death receptor) monoclonal antibody which acts as an immunomodulator by blocking ligand activation of PD-1 receptor on activated T-cells. It is approved for the use of metastatic melanoma, squamous non-small cell ling cancer and Hodgkin's lymphoma.

4. TRADE (BRAND) NAME- Unituxin
ACTIVE PHARMACEUTICAL INGREDIENT- Dinutuximab
COMPANY NAME- United Therapeutics
USE- Dinutuximab is a chimeric (human/mouse) monoclonal antibody developed for the pediatrics with high-risk neuroblastoma.



                                            APRIL 2015 US-FDA APPROVED DRUGS

1. TRADE (BRAND) NAME- Kybella
ACTIVE PHARMACEUTICAL INGREDIENT- Deoxycholic acid
COMPANY NAME- Kythera Biopharma
USE- Deoxycholic acid is one of the secondary bile acid which is the metabolic by-products of intestinal bacterial. It is used in the emulsification of fats for the absorption of intestine. It is used for destroying the moderate to high amount of fat below the chin in the submental triangle.

                                                       DEOXYCHOLIC ACID


2. TRADE (BRAND) NAME- Corlanor
ACTIVE PHARMACEUTICAL INGREDIENT- Ivabradine
COMPANY NAME- Amgen
USE- Ivabradine is a cardiotonic agent, anti-anginal agent whose mechanism differs the usual anti-anginal drugs like beta blockers, calcium channel blockers. It blocks the "funny" ion current which is highly active in the sinoatrial node. "Funny" ion current is a mixed sodium-potassium inward current activated by hyperpolarization. Thus, by blocking this ion current it slows the heart rate and reduces cardiac pace-maker activity. It is approved for the treatment of chronic heart failure.

IVABRADINE

                                                MAY 2015 US-FDA APPROVED DRUGS

1. TRADE (BRAND) NAME- Viberzi

ACTIVE PHARMACEUTICAL INGREDIENT- Eluxadoline
COMPANY NAME- Actavis
USE- Eluxadoline is a mu- and kappa- opioid receptor agonist and delta- receptor antagonist. It is a novel orally-acting drug acts locally on enteric nervous system and thus decreasing the adverse effects on central nervous system. It is approved for the treatment of irritable bovel syndrome (IBS) with diarrhea and abdominal pain.

                                                                 ELUXADOLINE

2. TRADE (BRAND) NAME- Xifaxan
ACTIVE PHARMACEUTICAL INGREDIENT- Rifaximin
COMPANY NAME- Salix Pharmaceuticals
USE- Rifaximin is a semi-synthetic antibiotic based on rifamycin. It is also approved for the treatment of IBS and thus relieving bloating and flatulence associated with it. Rifaximin binds to the beta subunit of bacterial RNA-polymerase and thus blocking translocation step, inhibiting transcription.

                                                                       RIFAXIMIN

3. TRADE (BRAND) NAME- Stiolto Respimat
ACTIVE PHARMACEUTICAL INGREDIENT- Tiotropium bromide and Olodaterol
COMPANY NAME- Boehringer Ingelheim
USE- Tiotropium bromide is a long acting anticholinergic (muscarinic receptor antagonist) bronchodilator used for the maintainance of COPD which includes chronic bronchitis and emphysema.
Olodaterol is a long acting beta-adrenoreceptor agonist used for the maintainance of COPD including chronic bronchitis and emphysema.

                                                              TIOTROPIUM BROMIDE

                                                                      OLODATEROL

DECEMBER- 2014 US-FDA APPROVED DRUGS

                                      DECEMBER- 2014 US-FDA APPROVED DRUGS
1. TRADE (BRAND) NAME- Opdivo
ACTIVE PHARMACEUTICAL INGREDIENT- Nivolumab
COMPANY- Bristol-Myers Squibb
USE- Nivolumab is a humanized IgG4 monoclonal antibody which acts as an immunomodulator by inhibiting the programmed cell death (PD-1) receptor. The blocking of PD-1 receptor is essentila for the treatment of cancer.
Opdivo is thus marketed for the treatment of unresectable or metastatic melanoma.

2. TRADE (BRAND) NAME- Soolantra Cream 1%
ACTIVE PHARMACEUTICAL INGREDIENT- Ivermectin
COMPANY- Galderma Labs
USE- Ivermectin is a broad-spectrum anti-parasitic drug and hence used for the treatment of a range of various parasitic diseases.
Rosacea is basically a chronic inflammatory disorder characterized by erythema (redness) of the facial skin and sometimes with pimples.
Soolantra Cream is approved for the treatment of inflammatory lesions of rosacea.

IUPAC name:- 22,23-dihydroavermectin B_1a + 22,23-dihydroavermectin B_1b
 
3. TRADE (BRAND) NAME- Signifor LAR
ACTIVE PHARMACEUTICAL INGREDIENT- Pasireotide
COMPANY- Novartis
USE- Pasireotide was an orphan drug used for the treatment of Cushing's Syndrome.
Acromegaly and Cushing's Syndrome have a common link that they are mainly caused due to adenoma (tumour of pituitary gland).
Pasiroetide is a somatostatin analogue and can thus can alleviate adenoma in both cases.

IUPAC name:- [(3S,6S,9S,12R,15S,18S,20R)-9-(4-aminobutyl)-3-benzyl-12-(1H-indol-3-ylmethyl)-2,5,8,11,14,17-hexaoxo-15-phenyl-6-[(4-phenylmethoxyphenyl)methyl]-1,4,7,10,13,16-hexazabicyclo[16.3.0]henicosan-20-yl] N-(2-aminoethyl)carbamate

4. TRADE (BRAND) NAME- Dyloject Injection
ACTIVE PHARMACEUTICAL INGREDIENT- Diclofenac Sodium
COMPANY- Hospira
USE- Diclofenac sodium is one of the most commonly used NSAIDs (Non-Steroidal Anti-Inflammatory Drug). It is an anti-inflammatory as well as analgesic drug.
This injection is thus used for the management of mild, moderate or severe pain.

5. TRADE (BRAND) NAME- Rapivab Injection
ACTIVE PHARMACEUTICAL INGREDIENT- Peramivir
COMPANY- Biocryst
USE- Peramivir is one of the latest entrants into the anti-viral drug category and was deeloped during the H1N1 epidemic that broke few years back.
It acts as an neuraminidase inhibitor and prevents the emergence of new viruses from the infected cells.
Rapivab Injection is used for the treatment of acute uncomplicated influenza in adults.

IUPAC name:-(1S,2S,3S,4R)-3-[(1S)-1-acetamido-2-ethyl-butyl]-4- (diaminomethylideneamino)-2-hydroxy-cyclopentane- 1-carboxylic acid

6. TRADE (BRAND) NAME- Saxenda Injection
ACTIVE PHARMACEUTICAL INGREDIENT- Liraglutide (r-DNA origin)
COMPANY- Novo Nordisk
USE- Liraglutide Injection is used for the treatment of type-2 diabetes by reducing the meal-related hyperglycemia and thus providing a better control on blood glucose level. It acts as glucagon-like peptide-1 (GLP-1) agonist and is well suited for chronic weight management.

7. TRADE (BRAND) NAME- Xtoro Suspension (0.3%)
ACTIVE PHARMACEUTICAL INGREDIENT- Finafloxacin
COMPANY- Alcon
USE- Finafloxacin is one of the new drug introduced in the fluoroquinine class of antibiotics. This otic suspension is approved for use of otitis externa. Otitis externa is an inflammatory disorder of the outer ear and ear canal.

8. TRADE (BRAND) NAME- Zerbaxa
ACTIVE PHARMACEUTICAL INGREDIENT- Ceftolozane and Tazobactam
COMPANY- Cubist Pharmaceuticals
USE- Ceftolozane is a an antibiotic belonging to cephalosporin class. It is effective against Gram negative bacteria which has developed resistance to all other antibiotics. It is therefore combined with tazobactam -a beta-lactamase inhibitor- since all the resistant micro-organisms will show resistance unless and until this enzyme is inhibited.
This combination is effective in treatment of complicated intra-abdominal and urinary tract infections.

Ceftolozane-

IUPAC NAME- (6R,7R)-3-([3-Amino-4-(2-aminoethylcarbamoylamino)-2-methylpyrazol-1-ium-1-yl]methyl)-7-([(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.

Tazobactam-

IUPAC NAME- (2S,3S,5R)-3-Methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide

9. TRADE (BRAND) NAME- Blincyto
ACTIVE PHARMACEUTICAL INGREDIENT- Blinatumomab
COMPANY- Amgen
USE- Blinatumomab is an anti-cancer drug which comes under the new class of monoclonal antibodies- Bi-specific T-cell engagers. As the name suggests, the drug molecule has 2 binding cites- a CD-3 site for T-cells and a CD-19 site for the target B-cells. It directs the patients T-cells to bind with malignant B-cells; thus by linking these cells, it activates the T-cell for its cytotoxic activity.
Blincyto is approved for the treatment of Philadelphia chromosome-negative relapsed/ refractory -cell precursor acute lymphoblastic leukemia.

10. TRADE (BRAND) NAME- Viekira Pak tablets
ACTIVE PHARMACEUTICAL INGREDIENT- Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir
COMPANY- Abbvie
USE- Ombitasvir is a NS5A inhibitor with pangenotypic antiviral activity (NS5A is a phosphoprotein that plays a role in Hepatitis C virus (HCV) replication.).
Paritaprevir is a NS3/4A serine protease inhibitor (NS3 is a nonstructural viral protein- a cleavage product of HCV and NS4 is a HCV protein).
Dasabuvir is a non-nucleotide NS5B inhibitor (NS5B- A HCV protein).
Ritonavir is a CYP3A4 inhibitor which increases the pharmacological actions of Paritaprevir.
Viekira Pak is thus used for the treatment of genotypic 1 chronic HCV,
 Ombitasvir:-

Paritaprevir:-

 Ritonavir:-

 Dasabuvir:-

11. TRADE (BRAND) NAME- Lynparza
ACTIVE PHARMACEUTICAL INGREDIENT- Olaparib
COMPANY- AstraZenca
USE- Olaparib is a poly ADP ribose polymerase (PARP) inhibitor. It is a anti-cancer agent used in patients with hereditary BRCA1 & 2 mutations.
Lynparza is thus usd for the treatment of previously treated BRCA mutated advanced ovarian cancer.

 Olaparib:-

 IUPAC name:- 4-[(3-[(4-cyclopropylcarbonyl)piperazin-4-yl]carbonyl) -4-fluorophenyl]methyl(2H)phthalazin-1-one