PharmaSages_May FDA Approvals

MERCK: LIPTRUZET*, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to: 1) reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. 2) reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. *Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug. WARNER CHILCOTT : WC3040 (norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets) is an estrogen/progestin combination oral contraceptive (COC) indicated for use by women to prevent pregnancy. ARBOR PHARMS: NYMALIZE is a dihydropyridine calcium channel blocker indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry an eurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V). GLAXO: BREO ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Important limitations: Not indicated for relief of acute bronchospasm or for treatment of asthma. BAYER: Xofigo* is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. *Priority review drug: A drug that appears to represent an advance over available therapy. GLAXO:TAFINLAR (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. GLAXO: MEKINIST (trametinib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDAapproved test.

Contact us
Ajay Shrivastava, CEO

PharmaSages 58 Magnolia Lane Princeton, NJ 08540 Phone: (609)423-7602

E-mail:asbiopro@pharmasages.com Web: www.pharmasages.com