Fierce Pharma February 12, 2024
After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S.
Monday, India’s Aurobindo said (PDF) it has received a final FDA approval for its generic form of PTC’s Emflaza for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 and older.
Aurobindo plans to launch generic deflazacort tablets at various dosage strengths this month, the company said in a release.
In the first nine months of 2023, Emflaza generated around $188 million, according to PTC’s quarterly releases from last year. The company has yet to report full-year 2023 results.
The drug has no remaining patents, according to FDA records. Its lone remaining period of FDA exclusivity covers DMD...
Today's Sponsors
Today's Sponsor