Generic Drug Launched for Pulmonary Arterial Hypertension

Teva Pharmaceutical Industries has launched a generic version of Gilead’s Letairis (ambrisentan) Tablets, 5 mg and 10 mg, in the United States.

Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening. In combination with tadalafil, ambrisentan is indicated to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.

For all female patients, ambrisentan tablets are only available through a restricted program called the Ambrisentan Risk Evaluation & Mitigation Strategy (REMS), due to the risk of fetal harm.

“The launch of ambrisentan tablets in the US is an important addition to Teva’s growing generic portfolio of nearly 60 cardiovascular medicines,” said Brendan O’Grady, EVP and Head of North America Commercial, in a prepared statement. “Our ability to help treat this disease is a testament to our commitment to providing affordable, generic treatment options to people living with chronic, life-long conditions.”

With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, according to the company.

Reference

Teva Announces Launch of a Generic Version of Letairis® (ambrisentan) Tablets in the United States [news release]. Jerusalem; May 1, 2019: Teva. https://www.businesswire.com/news/home/20190501005918/en. Accessed May 3, 2019.