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Zydus Secures USFDA Approval for Generic PAH Drug Bosentan
19 Feb 2026 20:13 GMT
… the United States Food and Drug Administration (USFDA) for … is the generic version of Tracleer® Tablets for Oral Suspension, … the treatment of Pulmonary Arterial Hypertension (PAH). The drug is … in the lungs. The medicine is generally administered according …
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Zydus Life gets FDA nod for children’s lung treatment drug bosentan
18 Feb 2026 13:16 GMT
… United States Food and Drug Administration (FDA) for bosentan tablets … the generic version of Tracleer® tablets for oral suspension … is indicated for the treatment of pulmonary arterial hypertension … Zydus Lifesciences settles bladder drug patent dispute with …
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Viagra and combination therapy reshape PAH treatment in systemic sclerosis
16 Dec 2025 02:58 GMT
… lives.
So, how did treatment outcomes improve?
Professor Jung highlighted … that early diagnosis and treatment of pulmonary arterial hypertension in … Current medications include endothelin pathway drugs, such as bosentan (sold as Tracleer) and …
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Lupin rolls out generic Tracleer
21 Aug 2025 18:14 GMT
… for its Abbreviated New Drug Application from the Food … and Drug Administration.
NATCO holds … day generic drug exclusivity.
[Read more: Lupin receives FDA OK … of Actelion Pharmaceuticals' Tracleer.
They are indicated for the treatment of …
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Natco Pharma introduces generic Bosentan in US for pulmonary arterial hypertension treatment
20 Aug 2025 08:52 GMT
… the US FDA for its Abbreviated New Drug Application and … have 180-day generic drug exclusivity.
Bosentan Tablets for … to Tracleer Tablets for Oral Suspension of Actelion Pharmaceuticals US, … Inc.
They are indicated for the treatment …
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Optum Rx Ends Reauthorization for Many Chronic Disease Drugs
19 Mar 2025 18:04 GMT
… term condition
Requires chronic treatment
Long-term drug effectiveness is established
… Ofev
Pulmonary arterial hypertension drugs: Revatio, Liqrev, Uptravi, Tracleer, Letairis, Adcirca, … for procedures and services in Medicare Advantage plans.
The healthcare …
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Hyderabad-based Natco Pharma gets FDA approval for marketing Bosentan Tablets in the United States
10 Feb 2025 10:54 GMT
… and Drug Administration (U.S.FDA) for Natco’s Abbreviated New Drug Application … equivalent of Tracleer Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc … Suspension are indicated for the treatment of pulmonary arterial hypertension (PAH …
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Lupin and Natco receive US FDA approval for generic Tracleer tablets for oral suspension
10 Feb 2025 10:17 GMT
… Food and Drug Administration (FDA) for Natco … Tracleer tablets for oral suspension of Actelion Pharmaceuticals … for the treatment of pulmonary arterial … pharmaceutical products, including branded and generic formulations, complex generics, biotechnology …
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GoodRx : 10 Bosentan (Tracleer) Side Effects and How to Manage Them
25 Jul 2024 22:38 GMT
… savings to related medications
info_outlinedPromotional disclosure … , causes, and treatments of PAH.
Portable … infection
During clinical trials, respiratory tract infections … Food and Drug Administration.
Actelion Pharmaceuticals US. (2024). Tracleer (bosentan …
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Human medicines European public assessment report (EPAR): Tracleer, bosentan, Date of authorisation: 14/05/2002, Revision: 43, Status: Authorised
02 May 2024 13:20 GMT
Treatment of PAH
In PAH, Tracleer film-coated tablets added … than placebo (a dummy treatment) in improving the distance … support the use of the medicine in this group.
In … weeks of treatment.
Treatment of systemic sclerosis with digital ulcers
Tracleer was …