HUMAN GROWTH HORMONE (hGH) APPLICATION REVIEWS

HUMAN GROWTH HORMONE (hGH) APPLICATION REVIEWS are proceeding at FDA for followup products to Genentech's Protropin and Lilly's Humatrope, the agency told Senators Kennedy (D-Mass.) and Hatch (R-Utah) in a Jan. 25 letter (see related story above). Noting that Kennedy and Hatch had asked that pending hGH application reviews be completed by June of this year, FDA reported "the review of those applications is ongoing, and we expect that much of the review work will have been completed by June 1989." The senators had asked FDA to complete its review by June so that any changes in orphan exclusivity provisions could be taken advantage of by the pending hGH products. Lilly's Humatrope has about five years of exclusive marketing rights remaining for its recombinant human growth hormone product. FDA included one proviso in its assurance of a continuing review of the pending hGH applications. The agency noted the exception "of those areas where evolving technology may result in different production methods." Genentech recently defended its pricing and marketing practices for Protropin in a Jan. 17 letter to the National Commission on Orphan Diseases. Noting that the average annual cost of Protropin is $ 12,000, the letter states that the price of Protropin, since its market introduction at "25% less than the price of the two pituitary-derived products that it replaced," has not changed.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Archive

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

 

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 

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 

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

 

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

More from Pink Sheet

Canada Unveils Draft List of Essential Drugs For Universal Pharmacare

 

The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Post-BIO Podcast: Thoughts From The Frontlines

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.