News & Events
Health Canada approves updated Estragyn Vaginal Cream™ labelling language and indication
Montreal, QC. Searchlight Pharma is pleased to announce the approval by Health Canada’s Therapeutic Products Directorate of the company’s supplemental New Drug Submission (sNDS) seeking to update the indication and labelling language for Estragyn Vaginal Cream™. Effective immediately, Estragyn Vaginal Cream™ is “indicated for the treatment of the symptoms of vulvovaginal atrophy due to estrogen deficiency”. Along with this change, Searchlight has updated the label and product monograph to align with Health Canada’s plain language guidance. The combined effect of these changes enhances the readability and understanding of the therapeutic use and benefits of Estragyn Vaginal Cream™ by healthcare professionals and consumers. The revised product monograph can be accessed and reviewed at www.searchlightpharma.com/monograph/estragyn_en.pdf
“We are very pleased to have been successful introducing these regulatory product updates in an efficient, timely manner,” said Mark Nawacki, President and CEO of Searchlight Pharma. “We strongly believe in the need for consumers and healthcare professionals to have access to accurate, up-to-date, and easy to understand information about effective, available medical treatment options. The changes approved by Health Canada via this sNDS speak directly to that need, and we hope will improve access and understanding of how Estragyn Vaginal Cream™ can play a role in the effective treatment of vulvovaginal atrophy, thereby improving the quality of life of Canadian women.”
About Estragyn Vaginal Cream™:
Estragyn Vaginal Cream™ is a prescription topical cream indicated for the treatment of the symptoms of vulvovaginal atrophy due to estrogen deficiency. It is the only non-animal derived, single ingredient topical product approved by Health Canada used to treat the dryness, itching and burning in and around the vagina due to a lack of estrogen. Containing 0.1% of estrone, a naturally occurring estrogen in the female human body, Estragyn Vaginal Cream™ is an alcohol-free, fragrance-free topical alternative to other local estrogen formulations available in Canada.
For more information about Estragyn Vaginal Cream™ or this regulatory update please contact Mark Nawacki at (514) 613-1513 or at firstname.lastname@example.org.