Pet therapeutics company Aratana Therapeutics Inc (Nasdaq:PETX) reported on Monday the receipt of approval from the US Food and Drug Administration's Center for Veterinary Medicine (CVM) for an additional vial size in 10 ml for NOCITA (bupivacaine liposome injectable suspension) for the management of pain in dogs and cats.
Currently, NOCITA is available in a 20 ml vial size only and the NOCITA in 10 ml vial is expected to be launched commercially by the autumn this year, added the company.
According to the company, NOCITA is US FDA-approved for single-dose infiltration into the surgical site to provide local post-operative analgesia for cranial cruciate ligament surgery in dogs and as a peripheral nerve block to provide regional post-operative analgesia following owner-elected onychectomy in cats.
The company said NOCITA (bupivacaine liposome injectable suspension) is for local infiltration injection in dogs as well as used as a peripheral nerve block in cats.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval