About Vernalis Therapeutics

Headquartered in Berwyn PA, Vernalis Therapeutics, Inc. is a US subsidiary of Vernalis plc, established to commercialize extended-release formulations of prescription products for the US market. These products are being developed in partnership with New Jersey based Tris Pharma, Inc.

The NDA for the lead product, Tuzistra® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII, was approved by the FDA on 30 April 2015 and the product was launched into the 2015/2016 cough cold season. Click here for full Prescribing Information for Tuzistra® XR, including Boxed Warning and here for the Medication Guide.

In October 2015, Vernalis also acquired the US rights to Moxatag®, a once-a-day amoxicillin for strep throat in adult and pediatric patients 12 years of age or older. Click here for full Prescribing Information for Moxatag®.

Vernalis Therapeutics, Inc. takes its responsibility as a pharmaceutical company seriously promoting and supporting a culture of integrity and compliance. 

Latest News

FDA Issues a Complete Response Letter on CCP-07 NDA

Vernalis plc announces today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-07.

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Fact Sheet

For more information on Vernalis, click below to download a copy of our fact sheet

 

Factsheet-Nov14

 

 

 

 

Contact Vernalis Therapeutics

T: 1-484-913-0700
F: 1-610-651 5976

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To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and drugsafety@propharmagroup.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch