Zydus Lifesciences Limited has informed the Exchange regarding a press release dated February 18, 2026, titled "Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg".
ZYDUSLIFE · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to market Bosentan tablets for oral suspension in the 32 mg strength. Bosentan is used to treat pulmonary arterial hypertension (PAH), a condition affecting blood vessels in the lungs. With this approval, Zydus can now launch the product in the US generic market, joining other approved manufacturers of this therapy. This adds to Zydus's growing portfolio of US-approved generic products and strengthens its presence in the US pharmaceutical market.
This approval adds a new product to Zydus's US generics portfolio, which could contribute incremental revenue from the US market. It is a positive development for the company's US business, though the financial impact may be modest given the niche nature of the product.