Dr Reddy's Laboratories on Tuesday announced that it has received US Food and Drug Administration (US FDA) final approval for its abbreviated new drug application (ANDA) for enlapril maleate and hydrochlorothiazide (HCTZ) tablets, a combination drug in the anti-hypertensive therapeutic segment.
Dr Reddy's has received approval for 5 mg/12.5 mg and 10 mg/25 mg dosage forms of the combination drug. This combination drug is the generic equivalent of Merck's anti-hypertensive drug Vaseretic. The final patent for the Vaseretic expired on September 18, 2001. Dr Reddy's plans to launch the drug in US market in about a month.
According to a company release, the brand product (Vaseretic) had an annual sales of approximately $69 million in 2000.
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Meanwhile, the company has allotted 56,694 equity shares of Rs 10 each to the shareholders of erstwhile American Remedies Ltd (ARL). This was pursuant to the orders of the High Courts of Andhra Pradesh and Madras sanctioning the scheme of merger of American Remedies Ltd with itself.
With the completion of the two-year old merger process on July 23, 2001, with retrospective effect from April 1, 1999, Dr Reddy's has fixed August 28, 2001 as the record date for conversion of ARL shares into Dr Reddy's shares. Since Dr Reddy's was holding 87 per cent stake in ARL, the effective increase in the equity of Dr Reddy's, consequent to the merger, was nominal.
The board of Dr Reddy's Labs at its meeting held on September 24, 2001 has decided to issue shares of Rs 10 each to the eligible shareholders of ARL and then subdivide them into Rs 5 each per share.