Homepage > Company > Media > Pharma News > 2021 > Catalyst wins favorable court ruling on orphan drug

Catalyst wins favorable court ruling on orphan drug

Catalyst Pharmaceuticals (NASDAQ:CPRX) won its appeal regarding the FDA decision to approve a rival amitriptyline product for which the company has Orphan Drug exclusivity.

Catalyst (CPRX) shares remain on hold for trading.

In the appeal, the 11th Circuit Court of Appeals has overturned the District Court decision to uphold the FDA approval of Ruzurgi for children with Lambert-Eaton myasthenic syndrome (LEMS) despite Orphan Drug status held by Catalyst (CPRX) for Firdapse (amifampridine) 10 mg tablets.

“The Court's decision adopted Catalyst’s core argument that the FDA’s approval of Ruzurgi® violated Catalyst's rights to Orphan Drug Exclusivity,” Catalyst (CPRX) said in a press release.

30 October 2021

https://newsfilter.io/

Read also

Pfizer touts Tukysa in front-line breast cancer after Phase III victory

Pfizer’s Tukysa (tucatinib) has enhanced patient outcomes when used as a maintenance therapy during a late-stage trial in breast cancer.

Telomir Pharmaceuticals reports new preclinical data on pancreatic cancer

Telomir Pharmaceuticals, Inc., a $54 million market cap biotech company whose stock has declined 11% in the past week

Компания 60 Degrees Pharmaceuticals

60 Degrees Pharmaceuticals Announces No Detection of Babesia Infection in First Patient Following Treatment with Tafenoquine in Relapsing Babesiosis Study

Gene Therapy Protects Kidneys in Preclinical Model of Type 1 Diabetes

One in three people with type one diabetes will develop kidney damage during their lifetime, which can develop silently over many years, often going undetected until it becomes severe.