NEW DRUG APPROVALS
·
Pertzye
(Pancrelipase) delayed release capsules: May 17, 2012
It is a combination of
porcine-derived lipases, proteases and amylases indicated for the treatment of
exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
·
Fabior
(Tazarotene) Foam: May 11, 2012
It is a retinoid
indicated for the topical treatment of acne vulgaris.
·
Elelyso
(Taliglucerase alfa): May 1, 2012
It is a plant-cell
expressed recombinant form of glucocerebrosidase for the treatment of Gaucher
Disease.
·
Dymista
(Azelastine and Fluticasone) Nasal spray: May 1, 2012
It is an H1-receptor
antagonist and corticosteroid combination indicated for the relief of seasonal
allergic rhinitis.
·
Stendra
(Avanafil) tablets: April 27, 2012
It is a
phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile
dysfunction.
·
Amyvid
(Florbetapir F 18) injection: March 27, 2012
It is a radioactive
diagnostic agent used for brain imaging of beta-amyloid plaques in patients who
are being evaluated for Alzheimer’s disease and other causes of cognitive
decline.
·
Omontys
(Peginesatide) injection: March 27, 2012
It is an
erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia
due to chronic kidney disease (CKD) in adult patients on dialysis.
·
QNASL
(Beclomethasone dipropionate) Nasal Aerosol: March 23, 2012
It is an intranasal corticosteroid non-aqueous
“dry” spray formulation for the treatment of seasonal allergic rhinitis and
perennial allergic rhinitis.
·
Binosto
(Alendronate) Effervescent tablets: March 12, 2012
It is a buffered
effervescent dosage form of the bisphosphonate drug alendronate sodium
administered once weekly for the treatment of osteoporosis.
·
Surfaxin
(Lucinactant) intratracheal suspension: March 6, 2012
It is a synthetic
peptide-containing surfactant indicated for the prevention of respiratory
distress syndrome (RDS) in premature infants.
·
Korlym
(Mifepristone) tablets: February 17, 2012
It is a cortisol
receptor blocker indicated to control hyperglycemia secondary to
hypercortisolism in adult patients with endogenous Cushing’s syndrome who have
Type 2 Diabetes Mellitus or glucose intolereance.
·
Bio-T-Gel
(Testosterone) Topical gel: February 14, 2012
It is a once-daily
transdermal testosterone gel for the treatment of male hypogonadism or low
testosterone levels.
·
Zioptan
(Tafluprost) ophthalmic solution: February 10, 2012
It is a prostaglandin
analog indicated for reducing elevated intraocular pressure in patients with
open-angle glaucoma or ocular hypertension.
·
Sklice
(Ivermectin) lotion: February 7, 2012
It is a pediculicide
indicated for the topical treatment of head lice infestations in patients 6
months of age and older.
·
Mitosol
(Mitomycin) ophthalmic solution: February 7, 2012
It is an antimetabolite
indicated as an adjunct to ab externo glaucoma surgery.
·
Kalydeco
(Ivacaftor) tablets: January 31, 2012
It is a cystic fibrosis
transmembrane conductance regulator (CFTR) potentiator indicated for the
treatment of cystic fibrosis in patients age 6 years and older who have a G551D
mutation in the CFTR gene.
·
Erivedge
(Vismodegib) capsules: January 30, 2012
It is a hedgehog
pathway inhibitor for the treatment of patients with advanced basal cell
carcinoma.
·
Jentadueto
(Linagliptin and Metformin hydrochloride) tablets:
January 30, 2012
It is a dipeptidyl
peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an
adjunct to diet and exercise to improve glycemic control in adults with type 2
diabetes mellitus.
Shamna
Sr Lecturer
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