Aurobindo Pharma Ltd has received approval from the US Food & Drug Administration (USFDA) to manufacture and market Tranexamic Acid Injection, (100 mg/mL) 1000 mg/10 mL single-dose vial and another approval to manufacture and market Paricalcitol Capsules, 1 mcg, 2 mcg, and 4 mcg.
While the first product is expected to be launched by the end of Q4 FY15-16, the second one will be launched in Q1 FY16-17, the company informed BSE.
The first approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Cyklokapron Injection, 100 mg/mL, of Pharmacia and Upjohn Company. Tranexamic Acid Injection is used in the treatment of short-term control of bleeding in haemophiliacs, including dental extraction procedures. The product is on the WHO’s list of essential medicines and has an estimated market size of $50 million for the 12 months ended November 2015, according to IMS.
This is the 22nd ANDA (including two tentative approvals) approved out of the Unit IV formulation facility in Hyderabad. Aurobindo now has a total of 232 ANDA approvals (201 final approvals, including 10 from Aurolife Pharma LLC and 31 tentative approvals) from USFDA.
Paricalcitol Capsules
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zemplar capsules 1 mcg, 2 mcg and 4 mcg of ABBVIE.
Paricalcitol Capsule is used for the prevention and treatment of parathyroid hormone in certain patients with chronic kidney disease. It has an estimated market size of $38 million for the 12 months ended November 2015, according to IMS.
This is the 58th ANDA to be approved out of the Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products.