Comments
Aurobindo Pharma Ltd has announced that the company has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil injection, 10mg/12.5mL (0.8mg/mL).
Sildenafil injection 10mg/12.5mL (0.8mg/mL) is a bioequivalent and therapeutically equivalent to the reference listed drug product, Revatio (sildenafil) injection, 10 mg/12.5 mL (0.8 mg/mL), of Pfizer.
Sildenafil injection is indicated for the treatment of adult patients (≥ 18 years) with pulmonary arterial hypertension who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.
This is the 9th ANDA (Abbreviated New Drug application) to be approved out of Unit IV formulation facility in Hyderabad, for manufacturing general injectable products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC, the company said in a press release.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.