FDA Approves Adhansia XR

STAMFORD, Conn.–(BUSINESS WIRE) March 01, 2019 –Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, a central nervous system (CNS) stimulant, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older. In a simulated Adult Workplace Environment (AWE) study, Adhansia […]

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FDA Approves Esperoct

Bagsværd, Denmark, 19 February 2019 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for Esperoct for the treatment of adults and children with hemophilia A. Esperoct is the brand name for turoctocog alfa pegol, N8-GP. Esperoct is indicated for use in adults and children with hemophilia A (congenital factor […]

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FDA Approves First Generic Version of Advair for Asthma, COPD

THURSDAY, Jan. 31, 2019 — The first generic form of the Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler has been approved by the U.S. Food and Drug Administration. The medication can now be used to treat children aged 4 years and older with asthma and adults with asthma or chronic obstructive pulmonary disease (COPD). The generic inhaler is […]

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FDA Approves First Biosimilar to Non-Hodgkin’s Lymphoma Drug

WEDNESDAY, Nov. 28, 2018 — Truxima (rituximab-abbs) has been approved by the U.S. Food and Drug Administration as the first biosimilar to the non-Hodgkin’s lymphoma drug Rituxan, the agency said today. Truxima, as with Rituxan, is approved to treat adults with CD20-positive, B-cell non-Hodgkin’s lymphoma to be used as a single agent or in combination with chemotherapy. The most common […]

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FDA Approves Powerful New Opioid, Dsuvia (Sufentanil), Despite Criticisms

FRIDAY, Nov. 2, 2018 — Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration on Friday approved an extremely potent new opioid painkiller, Dsuvia. The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. The tiny pill comes packaged in a […]

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FDA Approves Bijuva

BOCA RATON, Fla.–(BUSINESS WIRE)–Oct. 29, 2018– TherapeuticsMD, Inc, an innovative women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical* hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor […]

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