Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Mylan Pharmaceuticals Inc.

https://www.mylan.com

Latest From Mylan Pharmaceuticals Inc.

FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus

After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Generic Drugs Post Market Regulation & Studies

Draft Biosimilar Red Tape Elimination Act: Pharmacist As Ally, Would Patients Benefit?

If the bill on the Biosimilar Red Tape Elimination Act is passed, all biosimilars would be deemed interchangeable on US FDA approval. Scrip takes a look at what empowering pharmacists could mean, what the generics substitution experience shows and where possible pain points lie

Regulation Biosimilars

Aurobindo’s Pediatric AIDS Combo Generic Approved; Eugia Restructuring Back On Cards

A US FDA tentative approval for Aurobindo’s dolutegravir combination generic for children should increase access under the PEPFAR program and aid sales. On a Q1 earnings call, renewed efforts to restructure Eugia, biosimilar launch plans and fallouts of oral drug shortages and damage to Pfizer’s US injectables warehouse were discussed.

Approvals Strategy

Aurobindo’s Pediatric AIDS Combo Generic Approved; Eugia Restructuring Back On Cards

A US FDA tentative approval for Aurobindo’s dolutegravir combination generic for children should increase access under the PEPFAR program and aid sales. On a Q1 earnings call, renewed efforts to restructure Eugia, biosimilar launch plans and fallouts of oral drug shortages and damage to Pfizer’s US injectables warehouse were discussed

Commercial Approvals
See All

Company Information

  • Industry
  • Pharmaceuticals
UsernamePublicRestriction

Register