MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Cranbury Pharmaceuticals (Cranbury), a wholly-owned subsidiary of Tris Pharma, today announced the U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza® oral suspension (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD). The generic deflazacort oral suspension is now available to patients in the United States.
After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S.
Aurobindo Pharma`s Generic Deflazacort Receives Approval in the U.S.
OMAHA, Neb.--(BUSINESS WIRE)--Today, Amber Specialty Pharmacy announces that it will begin dispensing EMFLAZA® (deflazacort) to patients throughout the United States. EMFLAZA is manufactured by PTC Therapeutics, Inc., headquartered in South Plainfield, New Jersey, and is the first and only FDA-approved corticosteroid shown to slow the progression of Duchenne muscular dystrophy.
Overnight, Sarepta became more dependent on its Duchenne muscular dystrophy gene therapy project.
Sarepta’s DMD drug hit with FDA Complete Response Letter
In an unexpected decision, the Food and Drug Administration rejected Sarepta Therapeutics' experimental drug for Duchenne muscular dystrophy, issuing on Monday a Complete Response Letter to the rare disease biotech.
Three years ago, Sarepta pushed its first drug through a controversial approval, but its second drug is facing a different fate.
ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.