United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval
NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.
The FDA is scheduled to reach its decision this Saturday on United Therapeutics’ treprostinil diethanolamine sustained-release tablets for PAH, a potentially fatal disease that causes high blood pressure in the blood vessels of the lungs, according to the company. The company already markets inhaled and injected formulations of the drug under the brand names Tyvaso and Remodulin, respectively.
Meanwhile, Sandoz, the generics arm of Swiss drug maker Novartis, is seeking to market a generic version of Remodulin. United Therapeutics filed a lawsuit against Sandoz in March after the generic drug maker filed for approval of generic treprostinil injection in the 10-mL-per-mg strength. Sandoz said three patents covering Remodulin are invalid, unenforceable or won’t be infringed; United Therapeutics’ lawsuit puts a stay of final FDA approval on the generic version for up to 30 months. The patents are scheduled to expire between 2014 and 2029, according to FDA records.
Cardinal Health offers Dispill-USA drug packaging
DUBLIN, Ohio — Cardinal Health has introduced a new multidose drug packaging system that it said would help pharmacy customers adhere to medication regimens, the company said Tuesday.
Cardinal said each Dispill-USA blister pack contains 28 individual blisters, each for a specific intake time and containing all the medications a patient needs for a specific time of day, eliminating the need for patients to count out medications from multiple bottles multiple times per day. Cardinal said the system is easy and affordable for retail and long-term care pharmacies to implement, and the manufacturer offers a software program that interfaces with most pharmacy systems. Cardinal is the exclusive reseller of Dispill-USA packaging kits, blister packs, labels and other supplies, the company said.
"Dispill-USA multidose packaging kits are a great tool to empower pharmacists to make it easier than ever for their patients to ensure they’re being more adherent to their medication regimens," Cardinal Health president for U.S. pharmaceutical distribution Jon Giacomin said. "We also believe that pharmacies can leverage this packaging solution as a competitive differentiator, a great way to retain and attract patients who are looking for convenient, safe ways to improve their medication compliance."
Federal court orders FDA to allow Watson diabetes drug launch
PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.
Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda’s Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.
Watson filed suit against the FDA in August 2012, alleging that an agency decision to deny Watson’s claim to shared exclusivity in marketing a generic version of Actos would improperly delay its launch of the drug.
Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health.