Press Releases
Press Releases
FDA accepted Teva’s Fluticasone Propionate and Fluticasone Propionate RespiClick Inhalers
Teva Pharmaceutical Industries Ltd. announced that the U.S. FDA has accepted for review the company’s new drug applications (NDAs) for two products for adolescent and adult patients with asthma. The first, fluticasone propionate/salmeterol, is a fixed-dose...
Press Releases
Novo Nordisk receives the EMA marketing approval of the mylife YpsoPump insulin pump
Novo Nordisk announces the EMA marketing approval of the mylife(TM) YpsoPump® insulin pump for use with prefilled pump cartridge NovoRapid®PumpCart®. The approval is a key milestone for the collaboration between Novo Nordisk and Ypsomed and their goal to deliver...
Press Releases
Pfizer says Two additional late stage studies of cholesterol drug met goals
Pfizer Inc. announced two additional Phase 3 bococizumab trials, SPIRE-HR and SPIRE-FH , met their primary endpoint, demonstrating a significant reduction in the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at 12 weeks compared to placebo among...
Press Releases
Teva and Antares Pharma Announce Launch of Generic Imitrex in the United States
Teva Pharmaceutical Industries Ltd. and Antares Pharma, Inc. announced the launch of the generic equivalent to Imitrex injection, 4 mg and 6 mg single-dose, prefilled syringe autoinjectors, in the U.S. Sumatriptan injection is used to treat acute migraine with...
Press Releases
Teva and Antares Pharma Announce Launch of Generic Imitrex in the United States
Teva Pharmaceutical Industries Ltd and Antares Pharma, Inc. announced the launch of the generic equivalent to Imitrex®1 (sumatriptan succinate) injection, 4 mg and 6 mg single-dose, prefilled syringe autoinjectors, in the U.S. Sumatriptan injection is used to treat acute...
Press Releases
Teva Pharmaceutical Receives Positive CHMP Opinion on CINQAERO
Teva Pharmaceutical Industries Ltd announced that the EMA Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for CINQAERO® (reslizumab), a humanized interleukin 5 antagonist monoclonal antibody for add-on therapy in adult...
Press Releases
Mylan Launches Generic Version of Glaxo’s Avodart in U.S
Mylan N.V. announced the U.S. launch of Dutasteride Capsules, 0.5 mg, the generic version of GlaxoSmithKline's Avodart® Capsules. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for this product, which is indicated...
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