Solaris Pharma Corporation (“Solaris”) announced today that the U.S. Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for a generic version of Metrogel-Vaginal® (metronidazole vaginal gel 0.75%) by Bausch Health. This product will be launched immediately.
-- Current annual market for Metrogel-Vaginal totals $62 million –
-- Metronidazole vaginal gel 0.75% to launch immediately --
BRIDGEWATER, N.J., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Solaris Pharma Corporation (“Solaris”) announced today that the U.S. Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for a generic version of Metrogel-Vaginal® (metronidazole vaginal gel 0.75%) by Bausch Health. This product will be launched immediately.
According to IQVIA™ data, U.S. annual sales for metronidazole gel for the 12 months ended June 2021 totaled approximately $62 million.
“Solaris is pleased to provide patients access to another generic from its robust pipeline of semi-solid products. This timely FDA approval is further validation of our stellar in-house development, regulatory, and commercial capabilities, especially as we orchestrate a day-one launch. With a pipeline of many potential first-to-market products, we will continue to deliver on our commitment to provide high-quality, affordable medicine to the patients who can benefit,” said Satish Pejaver, Ph.D., Chief Executive Officer of Solaris.
About Solaris
Solaris Pharma Corporation, a privately held company headquartered in Bridgewater, NJ, is a specialty pharmaceutical company developing and commercializing high value drug products with limited generic competitors. Solaris is committed to development of complex dosage forms and 505(b)(2) products that bring value to patients by providing access to quality, affordable medicine.
Contact:
Satish Pejaver, Ph.D.
CEO
info@solaris-pharma.com
Source: Solaris Pharma Corporation
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ddd55f5f-717d-4e82-bbfb-1a8fe276e295
Solaris Pharma Receives FDA Approval for Generic Metrogel-Vaginal®
