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Cipher Pharmaceuticals Inc T.CPH

Alternate Symbol(s):  CPHRF

Cipher Pharmaceuticals Inc. is a specialty pharmaceutical company with a diversified portfolio of commercial and early to late-stage products, mainly in dermatology. The Company acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products in Canada, the United States, and South America. Its dermatology products include Actikerall, Epuris, and Vaniqa. Its hospital acute care products include Aggrastat and Brinavess. Its out-licensed products include Absorica, ConZip and Lipofen. Durela is its specialty medicine. Its product pipeline includes MOB-015, CF-101, and DTR-001. It delivers novel products to healthcare professionals and patients in Canada in a range of therapeutic areas, including dermatology, women’s health, urology and others. It also has the Natroba operations and global product rights to Natroba and its authorized generic Spinosad, a topical treatment for both head lice and scabies.


TSX:CPH - Post by User

Bullboard Posts
Post by pabalooon Apr 29, 2020 4:19pm
115 Views
Post# 30968284

Trevyent?

Trevyent?Looks like a bit of a wait for Trevyent.

Trevyent. We submitted a 505(b)(1) NDA to the FDA for our Trevyent disposable treprostinil pump system in June 2019. In April 2020, the FDA issued a complete response letter (CRL) related to our NDA indicating that some of the deficiencies previously raised by the FDA had not yet been addressed to its satisfaction. We are evaluating the letter and will provide updates on our plans to resubmit our NDA at a later date. We have one year from the date of the CRL to resubmit our NDA to the FDA, which is expected to trigger a six-month review period by the agency.
Bullboard Posts