Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX) reported on Monday the receipt of final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) for generic versions of Revatio (sildenafil citrate) and Amicar (aminocaproic acid).
Following the US FDA approval, the company has initiated the commercialization activities for Revatio for oral suspension in 10 mg/ml and Amicar tablets USP in 500 mg.
The company has received the US FDA Competitive Generic Therapy (CGT) designation for the generic version of Amicar and under the first approved application, the tablet has been granted with 180 days of CGT exclusivity.
For the 12 months ended 30 September 2019, the US market annual sales for the company's sildenafil citrate oral suspension and aminocaproic acid 500 mg tablets were estimated at about USD180m and USD23m, respectively, according to IQVIA,
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial