MASON, Ohio, Nov. 18, 2022 /PRNewswire/ -- Prasco Laboratories announced today the launch of the Authorized Generic of ZIOPTAN® (tafluprost ophthalmic solution) 0.0015%. This is Prasco's first Authorized Generic launch in partnership with Théa Pharma, Inc.
Sandoz's Generic Tafluprost Receives Approval in the U.S.
Santen EMEA has announced results from its real world evidence (RWE) study, VISIONARY, in which preservative-free Taptiqom (tafluprost/timolol) demonstrated statistically and clinically significant intraocular pressure (IOP) reductions in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).
Micro Labs India Generic Tafluprost Receives Approval in US
The U.S. FDA compiles a list of off-patent drugs without an approved generic to encourage the development of copycats. Now, the Chinese authorities are rolling out a similar initiative, only with some extra incentives.
Zioptan (tafluprost) : Santen Pharmaceutical v. Micro Labs USA Inc.
Sandoz’s Tafluprost Receives Supplemental Tentative Approval In US
On March 29, 2016, the United States Food and Drug Administration (FDA) updated its so-called Paragraph IV Certification List with two (2) new drugs for which the FDA has received abbreviated new drug applications (ANDAs) containing a patent challenge. The targeted new drug products are: (i) ApoPharma Inc.’s Ferriprox (Deferiprone) Tablets, 500mg; and (ii) Oak Pharmaceuticals, Inc.'s (a subsidiary of Akorn Pharmaceuticals) Zioptan (Tafluprost) Ophthalmic Solution, 0.0015%. The dates of submission of the respective ANDAs containing a patent challenge for these two new drug products are January 29, 2016 and February 10, 2016.
Mundipharma Ophthalmology Products has announced an agreement with MSD, known as Merck in the United States and Canada, to acquire MSD's ophthalmology portfolio for the treatment of increased ocular pressure caused by open angle glaucoma or ocular hypertension, in Australia, Canada, Latin America, Middle East, Africa and New Zealand.