Aurobindo Pharma has received final approval from the US FDA to manufacture and market Felodipine Extended-release tablets USP 2.5mg, 5mg, and 10mg. (ANDA 203417) and oxacillin for injection USP.
Felodipine Extended-release tablets USP 2.5mg, 5mg, and 10mg is the generic equivalent of AstraZeneca’s Plendil Extended-release tablets, 2.5mg, 5mg and 10mg and indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The annual sale of the product is approximately $64 million for the twelve months ending March 2012 according to IMS.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad. Aurobindo now has a total of 172 ANDA approvals (147 final approvals including two from Aurolife Pharma and 25 tentative approvals) from US FDA.
The company has also received to manufacture and market oxacillin for injection USP, packaged in 1g and 2g vials (ANDA 201539) and oxacillin for injection USP 10g/vial pharmacy bulk package (ANDA 201538). The products are ready for launch.
Oxacillin for injection USP is a sterile semisynthetic penicillin (SSP) indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug.
These ANDAs have been approved out of unit XII formulation facility in Hyderabad, India and will be marketed and sold by Aurobindo’s US subsidiary AuroMedics Pharma LLC.
Aurobindo now has a total of 174 ANDA approvals out of total 149 is final approvals including two from Aurolife Pharma LLC and 25 tentative approvals from US FDA.
EP News Bureau – Mumbai