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Omnitrope Clears FDA: Is the Next Hurdle Congress?

 
• By Kate Rawson

The debate over an abbreviated biologics pathway took a big step forward with the Food & Drug Administration's approval of Sandoz' recombinant human growth hormone Omnitrope. The approval itself is precedent setting, but the bigger ramifications are political: the action steps up the pressure on Congress to address the issue head-on.

The debate over an abbreviated biologics pathway took a big step forward with the Food & Drug Administration’s approval of Sandoz ’ recombinant human growth hormone Omnitrope. The approval itself is precedent setting, but the bigger ramifications are political: the action steps up the pressure on Congress to address the issue head-on.

FDA cleared somatropin (Omnitrope) for marketing in the US on May 30 under the 505(b)(2) regulatory pathway, which allows sponsors...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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New Drug Procurement Rules Aim To Drive Pharma Investment In Mexico

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
• By Michael McCaughan

The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.