Sunday, 6 July 2014

JUNE 2014 US-FDA APPROVED DRUGS


1.Trade (Brand) Name-Jublia
Active pharmaceutical ingredient-Efinaconazole- 10% topical gel;
Company- Valeant Pharmaceuticals;
Use-For the treatment of onychomycosis of the toenails.
Onychomycosis is nothing but fungal infection of the nails which results in discoloration and brittleness of nails such that they appear yellowish, greenish etc and break off easily.
Efinaconazole is a tetrazole ring containing anti-fungal agent which acts as an lanosterol-14-alpha demethylase inhibitor. This enzyme (lanosterol-14-alpha demethylase) is a CYP450 enzyme which catalyzes the demethylation step for the synthesis of ergosterol-an important constituent of fungal cell wall.



IUPAC Name-(2R,3R)-2-(2,4-Difluorophenyl)-3-(4-methylene-1-piperidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol

2.Trade (Brand) Name-Sivextro

Active pharmaceutical ingredient- Tedizolid phosphate
Company- Cubist Pharmaceuticals;
Use-For the treatment of acute bacterial skin and skin structure infections.
Tedizolid is an oxazolidinone prodrug (of the same class as that of Linezolid) used especially for Methicillin-resistant Staphylococcus aureus (MRSA) infections.


IUPAC Name-((5R)-3-(3-Fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxooxazolidin-5- yl)methyl hydrogen phosphate

3.Trade (Brand) Name-Afrezza (insulin human) Inhalation Powder;

Company- Mannkind;
Use-For the treatment of diabetes mellitus,
Afrezza is an ultra-rapid acting inhale-able insulin used for Type 1 as well as Type 2 diabetes with a label restriction for patients with asthma,COPD and other lung diseases.

4.Trade (Brand) Name-Vogelxo

Active pharmaceutical ingredient-Testosterone
Dosage form- gel
Company-Upsher-Smith;
Use- For males with a deficiency or absence of endogenous testosterone,
Testosterone is a anabolic male steroid hormone which is used for the normal development of primary as well as secondary male sexual characters. It is also used for the prevention of osteoporosis.



IUPAC Name-(8R,9S,10R,13S,14S,17S)- 17-Hydroxy-10,13-dimethyl- 1,2,6,7,8,9,11,12,14,15,16,17- dodecahydrocyclopenta[a]phenanthren-3-one

5. Trade (Brand) Name-Bunavail

Active pharmaceutical ingredient-Buprenorphine and Naloxone;
Company- BioDelivery Sciences;
Use- For the maintenance treatment of opioid dependence,
Bunavail is a combination formulation containing Buprenorphine and Naloxone
Buprenorphine is a semi-synthetic drug used for treatment of opioid addiction. It acts as a partial agonist of mu opioid receptors and nociceptin (pain receptors)-ORL-1 and an antagonist of delta and kappa opioid receptors.




IUPAC Name(Buprenorphine)-(2S)-2-[(5R,6R,7R,14S)-9α-Cyclopropylmethyl-4,5-epoxy-6,14-ethano-3-hydroxy-6-methoxymorphinan-7-yl]-3,3-dimethylbutan-2-ol

Naloxone is a pure opioid competitive antagonist with high affinity towards mu receptors and less affinity towards kappa and delta receptors used for the treatment of opium/heroin/morphine over dosage and also for treatment of opioid dependence.



IUPAC Name(Naloxone)-(1S,5R,13R,17S)- 10,17-dihydroxy- 4-(prop-2-en-1-yl)- 12-oxa- 4-azapentacyclo [9.6.1.01,13.05,17.07,18] octadeca- 7(18),8,10-trien- 14-one

6. Trade (Brand) Name-Eloctate 

Active pharmaceuical ingredient-Antihemophilic Factor (Recombinant), Fc Fusion Protein] 
Company- Biogen IDEC.;
Use- Only for the treatment of hemophillia A and not other bleeding disorders.
It is the 1st Recombinant Factor-VIII therapy with prolonged circulation in the body.

                                                                                                                                                    -Darwin