New Delhi: Zydus Lifesciences on Wednesday said it has received tentative approvals from the US health regulator to market two generic drugs, used for lowering blood pressure and for controlling diabetes, in the American market. The company has received tentative approval from the US Food and Drug Administration (USFDA) to market Bosentan Tablets for oral suspension in 32 mg strength, the drug maker said in a regulatory filing.
Bosentan Tablet for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) in pediatric patients aged three years and older.
The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad, it said. As per the latest IQVIA data, Bosentan Tablets for oral suspension had annual sales of USD 16 million in the US.
In a separate filing, the company said it has also received tentative approval from USFDA to market canagliflozin tablets of strengths 100 mg and 300 mg.
The canagliflozin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, the company added.