We are pleased to report a new Phase II clinical program. We have been awarded just over $1 million in funding from the FDA through their Orphan Drug Grant initiative to advance our ifetroban pipeline. As a result, we have now initiated a Phase II study for the clinical development of ifetroban for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD). It’s a rare, fatal, genetic neuromuscular disease for which there is currently no universally effective treatment. Our study is the first DMD clinical study approved for FDA Orphan Product Development funding.


Earlier in the year, we announced a strategic review of our brands, capabilities and international partners. Below is a summary of our decisions from the past quarter.


  • We added new international partners and expanded our corporate, sales and medical teams during the first half of the year.


  • Vibativ®: We finalized an agreement with Dr. Reddy’s Laboratories for the registration and distribution of Vibativ in India. Dr. Reddy's is a multinational pharmaceutical company based in Hyderabad, India that markets over 190 medications through its commercial operations in more than 35 countries.


  • Caldolor®: We filed a label update with the FDA in support of a Caldolor, aiming to further expand the product’s label. This update includes geriatric, shortened infusion, pediatric and PK data. In early September, the FDA informed us that our submission was not accepted for their review due to the number of new claims. They have offered a Type A meeting to discuss their recommendations, which we intend to schedule later this year.


  • RediTrexTM: We had several favorable communications with the FDA for our RediTrex (methotrexate) product line. The FDA has requested additional time to review our application and has set an approval decision date for December 2019.


As we enter the last quarter of 2019, we remain focused on advancing our mission of improving patient care through the delivery of high-quality pharmaceutical products.