Sunday, 18 January 2015

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 B1a + 22,23-dihydroavermectin B1b
 
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

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