FDA Approves Bosentan for Treatment of Pulmonary Arterial Hypertension

“Bosentan Tablets, 62.5 mg and 125 mg have an estimated market size of $68 million for twelve months ending September 2019.”


On Friday, an Indian-based pharma company, Alembic Pharmaceuticals Ltd (Alembic), said that it has received approval from the U.S. Food and Drug Administration for Bosentan (Tracleer) tablets for the treatment of pulmonary arterial hypertension.

“Having pulmonary arterial hypertension means that you have high blood pressure in the arteries that go from your heart to your lungs. It’s different from having regular high blood pressure,” according to WebMD.

The company said in a BSE (Bombay Stock Exchange) filling, “Alembic Pharmaceuticals Ltd. today announced it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application (ANDA) Bosentan tablets, 62.5 mg and 125 mg.”

Bosentan has been found effective at treating the symptoms of pulmonary arterial hypertension.

The filing said, “ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tracleer Tablets, 62.5 mg and 125 mg, of Actelion Pharmaceuticals Ltd.”

“Bosentan Tablets, 62.5 mg and 125 mg have an estimated market size of USD 68 million for twelve months ending September 2019,” according to IQVIA.

Formerly called Quintiles and IMS Health, IQVIA is an American multinational company that serves the combined industries of health information technology and clinical research.

Alembic has a total of 114 ANDA approvals from the FDA. Per-share of Alembic was trading at INR 597.85 ($8.37) on the BSE in the morning trade, which increased by 1.32 percent from the previous close.