Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Tenormin(R)
DETROIT, July 11 – Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for Atenolol Tablets USP (atenolol).
Atenolol is indicated in the management of hypertension, long-term management of patients with angina pectoris and in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Our generic atenolol is the bioequivalent to Tenormin(R), a registered trademark of AstraZeneca Pharmaceuticals LP. According to IMS Data, for the twelve months ended March 2007, atenolol generic and brand products (Tenormin(R)) combined had annual sales of approximately $102 million. Caraco has three strengths available, 25mg, 50mg and 100mg tablets.
Daniel H. Movens, Caraco’s Chief Executive Officer, said, “We are pleased to gain an approval from the FDA on this well established product used in managing hypertension. Our focus continues to be working towards expanding our product line effectively, including products that are already available generically in the market that potentially can add measurable value. We plan to market this product to the generic pharmaceutical market immediately. This will bring our total product selection to 35 different products represented by 73 various strengths.”
|Drug Name(s)||ATENOLOL (Generic Drug)|
|FDA Application No.||(ANDA) 078210|
|Original Approval Date||July 10, 2007|