Press Releases

EU approves Astrazeneca Plc’s New Antibiotic Zavicefta

AstraZeneca announced that the EC has granted marketing authorisation for Zavicefta , a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation. The approval includes intravenous use of Zavicefta for...

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...

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...

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...

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...

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...

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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