FDA APPROVED DRUGS(2015) IN MAJOR THERAPEUTIC AREAS

FDA APPROVED DRUGS(2015) IN MAJOR THERAPEUTIC            AREAS

BY, ROHINI S.P.

PHARM.D 2^ND YEAR, Dept of Pharmacy Practice, Alshifa College of Pharmacy

1)   CARDIOLOGY/VASCULAR DISEASES

a)    Prestalia :(Symplmed Pharmaceuticals) Prestalia is a combination of perindopril, an ACE inhibitor, and amlodipine, a calcium channel blocker.

Prestalia is supplied as a tablet for oral administration.  The recommended starting oral dose of Prestalia is 3.5/2.5 mg once daily. The dose may be adjusted according to blood pressure goals waiting 1 to 2 weeks between titration steps. The maximum recommended dose is 14/10 mg once daily.

b)   Savasya: (Daiichi Sankyo)Savaysa (edoxaban) is a Factor Xa inhibitor and works as an anticoagulant.Savaysa is specifically indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Savaysa is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE

2)   GASTROENTEROLOGY

a)    Avycaz : (Actavis) Avycaz (ceftazidime-avibactam) is a combination of a cephalosporin and a beta-lactamase inhibitor.Avycaz in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI)

Avycaz is supplied as a solution for intravenous infusion. The recommended dosage of Avycaz is 2.5 grams (2 grams ceftazidime and 0.5 grams avibactam) administered every 8 hours by intravenous (IV) infusion over 2 hours.

b)   Chlobam( Asklepion Pharmaceuticals) Cholbam (cholic acid) is a primary bile acid synthesized from cholesterol in the liver. Patients with bile acid synthesis disorders due to single enzyme defects with peroxisomal disorders (including Zellweger spectrum disorders) lack the enzymes needed to synthesize cholic acid, a primary bile acid normally produced in the liver from cholesterol.Cholbam is approved for use in children aged three weeks and older, and adults. Cholbam is supplied as a capsule for oral administration. The recommended dosage is 10 to 15 mg/kg administered orally once daily.

3)GYNAECOLOGY

a)Ibrance : (Pfizer) Ibrance (palbociclib) is an orally available pyridopyrimidine-derived cyclin-dependent kinase (CDK) inhibitor with antineoplasticactivity.Ibrance is specifically indicated for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.Ibrance is supplied as a capsule for oral administration. The recommended dose of Ibrance is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days.

4)   PAEDIATRIC

a)Bexsero (Novartis) : Bexsero is a multicomponent Meningococcal Serogroup B vaccine.Bexsero is specifically indicated for active immunization to prevent invasive disease caused by Neisseria meningitidisserogroup B. Bexsero is supplied as a solution for intramuscular administration. Bexsero should be administer in two doses (0.5 mL each) at least 1 month apart.

b)Unituxin (United Therapeutics) : Unituxin (dinutuximab) is a chimeric monoclonal antibody. Unituxin is specifically indicated for use in combination with granulocyte-macrophage colonystimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Unituxin is supplied as a solution for intravenous infusion. The recommended dose of Unituxin is 17.5 mg/m2 /day administered as an intravenous infusion over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles. Unituxin should be initiated at an infusion rate of 0.875 mg/m2 /hour for 30 minutes. The infusion rate can be gradually increased as tolerated to a maximum rate of 1.75 mg/m2 /hour.

5)   PULMONOLOGY

Opdivo: ( Bristol-Myers Squibb) Opdivo (nivolumab) is a human monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.Opdivo is specifically indicated for the treatment of patients with metastatic squamous nonsmall cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Opdivo is supplied as a solution for intravenous infusion. The recommended dose is 3 mg/kg I.V. over 60 minutes.

BY, ROHINI S.P.

PHARM.D 2^ND YEAR