The company now has a total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from USFDA.
Alembic Pharmaceuticals share price touched 52-week high of Rs 943, up 6 percent intraday on June 16 after the company received USFDA final approval for Deferasirox Tablets.
The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Deferasirox Tablets, 180 mg, as per company release.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jadenu Tablets, 180 mg, of Novartis Pharmaceuticals Corporation (Novartis), it added.
Deferasirox tablets are indicated for the treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) and for treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes.
Alembic had previously received final approval for Deferasirox Tablets, 90 mg and 360 mg and tentative approval for Deferasirox Tablets, for 180 mg.
Deferasirox Tablets, 180 mg have an estimated market size of USD 53 million for twelve months ending March 2020, according to IQVIA.
The company now has a total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from USFDA.
At 10:53 hr,s Alembic Pharmaceuticals was quoting at Rs 923.45, up Rs 33.45, or 3.76 percent on the BSE.Join the Moneycontrol Rule the New Normal powered by Lenovo webinar on the 18th of June. REGISTER NOW!
