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news.FDA accepts Symplmed’s Prestalia NDA
Prestalia, which is the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate, is indicated for the treatment of hypertension in the U.S. Perindopril is a
Prestalia, which is the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate, is indicated for the treatment of hypertension in the U.S. Perindopril is a
The investigational, all-oral, interferon-free medicine is primarily indicated for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The three direct-acting antiviral
Soliris (eculizumab) is currently approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It is not approved in any country
Designed to deliver brief, controlled pulses of nitric oxide, a selective, short-acting pulmonary vasodilator that are inhaled by the patient, the portable device INOpulse enables the treatment of
Manufactured in accordance with the current GMP standards, the therapeutic vaccine is based on a blend of inactivated lactobacilli strains. The primary endpoint of the double-blind and placebo-controlled
The bivalent rLP2086 vaccine is indicated for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25-year-olds. Pfizer vaccine research and development
According to IMS, for the year ended April 2014 total sales of Codeine Sulfate Tablets USP 15mg, 30mg and 60mg at Average Wholesale Price (AWP) were about $4.3m.
Novartis’ facility in Holly Springs is the first US facility of its kind and is now approved for commercial production. The facility will produce seasonal and pre-pandemic influenza
Based on the FDA feedback, the company will be moving into Phase II/III on one NDA Program, and into Phase II on the other. In line with the
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