Mylan’s recent developments
Mylan’s (MYL) recent developments include commercial as well as product developments. Let’s take a look at those developments.
Recent commercial developments for Mylan include the following:
Below are some of Mylan’s recent product developments:
- On December 29, 2016, Mylan received approval from the FDA (U.S. Food and Drug Administration) and launched a generic version of Concerta, a product of Johnson & Johnson’s (JNJ) subsidiary Janssen, for the treatment of attention-deficit/hyperactivity disorder.
- On December 29, 2016, Mylan launched a generic version of Pfizer’s (PFE) Cerebyx Injection for the treatment of severe seizures.
- On December 28, 2016, Mylan launched a generic version of Zovia tablets used to prevent pregnancy in women.
- On December 16, 2016, Mylan launched a generic version of the EpiPen Auto-Injector at a wholesale acquisition cost (or WAC) of $300 for a pack of two auto-injectors.
Below are a few of Mylan’s other product developments:
- On November 8, 2016, Mylan, in collaboration with Biocon, submitted a BLA (Biologics License Application) to the FDA (U.S. Food and Drug Administration) for a biosimilar of the drug trastuzumab for the treatment of HER2+ breast and gastric cancer. Trastuzumab is the international non-proprietary name for Genentech’s Herceptin.
- On November 3, 2016, Mylan and Biocon announced that the European Medicines Agency had accepted for review the Marketing Authorization Application for insulin glargine.
- On November 2, 2016, Momenta Pharmaceuticals (MNTA) and Mylan announced the initiation of a Phase 1 clinical study to compare the safety, immunogenicity, and pharmacokinetics of the drug M834, a proposed biosimilar of Bristol-Myers Squibb’s (BMY) Orencia.
Mylan has more than 250 ANDAs (Abbreviated New Drug Applications) pending FDA approval.
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