Ahmedabad based pharma major Zydus Cadila has got a shot in the arm as it has received three product approvals from the United States Food and Drug Administration (USFDA) in quick succession.
The group has received approvals to market Lamotrigine chewable tablets in strengths of 2 mg, 5 mg and 25 mg, Lamotrigine tablets — 25 mg, 50 mg, 100 mg, 150 mg, 200mg and 250 mg and Divalproex Sprinkle Capsules, 125 mg.
The branded sales in the US market of Lamotrigine chewable tablets was estimated at USD 101 million and that of Lamotrigine tablets was estimated at USD 2.4 billion in 2008 as per National Drug Code (NDC). The sales of Divalproex Sprinkle capsules were estimated at USD 63 million in 2008 as per NDC. All three products fall under the anti-epileptic segment.
The company will market all the three drugs through its US subsidiary Zydus Pharmaceuticals (USA) Inc. The group now has 44 approvals since the commencement of filing process in FY 2003-04. So far, the group has filed 80 Abbreviated New Drug Applications (ANDAs) and 71 Drug Master Files (DMFs).