Search result for 'paragraph iv certification'

Alembic Pharmaceuticals has received USFDA approval to market generic Ticagrelor Tablets, a medication for preventing heart attack and stroke. The drug is therapeutically equivalent to...

Natco Pharma has submitted an ANDA to the USFDA for a generic version of Novartis' Tabrecta, a cancer drug. The company expects to be eligible for 180 days of marketing exclusivity.

Alembic Pharmaceuticals receives tentative USFDA approval for its generic Selexipag injection, a treatment for pulmonary arterial hypertension. The company may be eligible for 180 days of generic...

Zydus Lifesciences has partnered with MSN Laboratories to bring a generic version of the cancer drug Cabozantinib to the US market, aiming to provide affordable treatment options.

Zydus Lifesciences receives USFDA approval for its generic version of Ivabradine tablets, indicated for the treatment of heart failure. The drug will be manufactured in Ahmedabad, India.