FDA pipeline preview

Complete response

New Drug Application for efinaconazole (Valeant Pharmaceuticals) for the treatment of onychomycosis. The questions raised by FDA in the complete response letter pertain only to Chemistry, Manufacturing, and Controls related areas of the container closure apparatus. As no efficacy or safety issues were raised by FDA, Valeant believes that these items can be addressed and is working for a timely response to FDA as soon as possible.

New drug application for levetiracetam (Sun Pharma) extended release tablets, 100 mg and 1,500 mg, for the treatment of epilepsy. In the complete response letter, FDA specified that the clinical data submitted by Sun Pharma establishes bioequivalence in the fasted state. However, FDA has raised certain queries on the pharmacokinetic data in the fed state. Sun Pharma is evaluating the contents of the letter and plans further discussions with FDA.

Priority review

Simeprevir (TMC435) (Janssen), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane, Celgene) supplemental New Drug Application (sNDA) for the use in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.

Fast-track designations

Investigational direct-acting antiviral (DAA) combination with and without ribavirin (AbbVie) for the treatment of genotype 1 hepatitis C virus infection has been designated as a breakthrough therapy.

Ceftolozane/tazobactam (CXA-201) in the previously granted Qualified Infectious Disease Product indications, hospital-acquired Bacterial Pneumonia/ventilator-associated bacterial pneumonia, and complicated urinary tract infections. 

Orphan drug designation

JX-594, pexastimogene devacirepvec (Pexa-Vec, Jennerex Biotherapeutics) for the treatment of hepatocellular carcinoma.

First-time generic approval

Candesartan cilexetil (equiv to Atacand) in 4-mg, 8-mg, 16-mg, and 32-mg strength tablets.

Sandoz