Company

Product

Description

Indication

Status

Evoke Pharma Inc., of Solana Beach, Calif.

Gimoti (metoclopramide)

Nasal spray formulation of metoclopramide

Diabetic gastroparesis

FDA accepted for review the 505(b)(2) NDA seeking approval for relieving symptoms of acute and recurrent diabetic gastroparesis in adult women; PDUFA date is April 1, 2019

Rafael Pharmaceuticals Inc., of Newark, N.J.

CPI-613

Altered energy metabolism-directed drug

Peripheral T-cell lymphoma

FDA granted orphan designation

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong

Midazolam oromucosal solution

Benzodiazepine

Seizures

China's Center for Drug Evaluation granted priority review designation as a pediatric medicine for the category 3 generic drug

Sirnaomics Inc., of Gaithersburg, Md.

STP-705

siRNA therapeutic

Advanced cholangiocarcinoma

FDA cleared the IND

Sun Pharmaceutical Industries Ltd., of Mumbai, India

Cequa (cyclosporine ophthalmic solution) 0.09%

Calcineurin inhibitor immunosuppressant

Dry eye syndrome

Approved by FDA

Vertex Pharmaceuticals Inc., of Boston

Kalydeco (ivacaftor)

CFTR potentiator

Cystic fibrosis

Approved by FDA to include use in children, ages 12 months to 24 months who have at least 1 mutation in their CFTR gene that is responsive to Kalydeco based on clinical and/or in vitro assay data

Wave Life Sciences Ltd., of Cambridge, Mass.

WVE-210201

Stereopure oligonucleotide

Duchenne muscular dystrophy

FDA granted orphan drug designation


Notes

For more information about individual companies and/or products, see Cortellis.

 

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