Pulmonary arterial hypertension (PAH) is known to be a progressive disorder which is characterized by hypertension or high blood pressure. This type of hypertension may damage the arteries of the lungs and may affect the right side of the heart and may turn critical if not diagnosed properly. Some of the symptoms include Pulmonary hypertension symptoms include shortness of breath while exercising, fainting smell, chest pressure, heart palpitations and dizziness in few cases. The pulmonary hypertension can be life threatening but has to be treated. The cause of the disease is unknown however it may be due to a congenital heart disease or due to the use of some medicated drugs. As per research, Pulmonary venous hypertension is very common in India due to the large prevalence of rheumatic valvular heart disease and contributes to a large majority of patients with severe pulmonary hypertension.
Alembic Pharmaceuticals Limited today announced that its wholly-owned subsidiary Alembic Global Holding SA has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL), Multiple-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Remodulin Injection, 20 mg/20 mL (1mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10mg/mL), of United Therapeutics Corp. (United). Treprostinil Injection is indicated for the treatment of pulmonary arterial hypertension (PAH;WHO Group 1) to diminish symptoms associated with exercise. In patients with PAH requiring transition from epoprostenol, Treprostinil Injection is indicated to diminish the rate of clinical deterioration. Alembic had previously received tentative approval for this ANDA.
Treprostinil Injection has an estimated market size of US$ 17 million for twelve months ending December 2020 according to IQVIA. Alembic now has a total of 138 ANDA approvals (121 final approvals and 17 tentative approvals) from USFDA, including this first injectable ANDA approval.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.