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FDA Approved 2015


The FDA gave the green light in late May 2015 with their approval of a quarterly dosing schedule of Paliperidone Palmitate, also known as Invega Trinza. Marketed by Janssen Pharmaceuticals this novel dosing regimen is the first ever quarterly dosing therapy for patients with Schizophrenia. Paliperidone is dispensed to patients via an intramuscular injection every[…]

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On July 24, 2015 the FDA approved Sonidegib, marketed by Novartis AG as the once daily pill Odomzoa for the treatment of locally advanced basal cell carcinoma. Specifically for patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy. Sonidegib,[…]

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On July 2, 2015 the FDA announced its approval for the potent duo of Lumacaftor and Ivacaftor to treat patients suffering from Cystic Fibrosis (CF). Coined Orkambi, which is marketed by Vertex Pharmaceuticals, this effectual treatment is specifically approved for patients ages 12 and older who have the homozygous F508 mutation of the CF transmembrane[…]

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Entresto, the novel combination therapy which combines Sacubitril and Valsartan, was FDA approved on July 7, 2015. Previously known as the investigational compound LCZ696, Entresto received an FDA nod to reduce the risk of both hospitalization and cardiovascular mortality in patients with chronic heart failure, especially those with a reduced ejection fraction and an NYHA[…]

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On February 3, 2015 the FDA approved Olopatadine Hydrochloride, ophthalmic solution 0.7%, for the treatment of ocular itching due to allergic conjunctivitis. Known as the brand name Pazeo, which is marketed by Alcon, the approved dose is one drop in each affected eye daily. Positive data from two trials coined Conjunctival Allergen Challenge demonstrated that[…]

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As an effectual oral factor Xa inhibitor, Edoxaban is FDA approved as a novel anticoagulant therapy in the U.S. as an anticoagulant in several capacities: To reduce the risk with of both systemic embolism and stroke in patients afflicted with atrial fibrillation (AF), which is not related to heart valve problems. As a treatment for patients[…]

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On January 5, 2015 Jubilant Life Sciences received an FDA nod for their Rizatriptan generic formulation, paving the way for more generic forms of Merck’s blockbuster migraine medication Maxalt. The strengths approved for generic production are both 5 milligrams and 10 milligrams, which makes up an estimated 70 million dollar market. Rizatriptan is an efficacious[…]

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