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Pharma sages aug fda approvals
1. PharmaSages_Aug FDA Approvals
VIIV HLTHCARE: TIVICAY (DOLUTEGRAVIR) is a human immunodeficiency virus
type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination
with other antiretroviral agents for the treatment of HIV-1infection in adults and
children aged 12 years and older and weighing at least 40kg.
HANMI USA INC: Esomeprazole strontium is a proton pump inhibitor indicated for
adults for:
• Treatment of gastroesophageal reflux disease (GERD)
• Risk reduction of NSAID-associated gastric ulcer
• H. pylorieradication to reduce the risk of duodenal ulcer recurrence
• Pathological hypersecretory conditions, including Zollinger-Ellison syndrome
Following drugs got new formulation or new manufacturer approvals
1) ZOLEDRONIC ACID from ACS DOBFAR INFO SA for hypercalcemia of malignancy and patients with
multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with
standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one
hormonal therapy.
2) VALCHLOR (MECHLORETHAMINE) from CEPTARIS THERAPEUTICS INC for topical treatment of Stage
IA and IB mycosis fungoides-type cutaneous T-cell lymphoma.
Following drugs got new dosage approvals
1) EPANED (ENALAPRIL MALEATE) from SILVERGATE PHARMA INC for treatment of hypertension.
2) TROKENDI XR (TOPIRAMATE) from SUPERNUS PHARMACEUTICALS INC for partial Onset Seizure and
Primary Generalized Tonic-Clonic Seizures and Lennox-Gastaut Syndrome (LGS) .
3) MIRVASO (BRIMONIDINE) from GALDERMA LABS or the topical treatment of persistent (nontransient)
facial erythema of rosacea.
2. 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