Lupin receives Final FDA Approval for Generic LoSeasonique® Tablets

Lupin believes that it is one of the first applicants to file an ANDA for LoSeasonique® Tablets and will be entitled to 180 days of marketing exclusivity

Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin pharmaceuticals Inc. (LPI) has received final approval for its Levonorgestrel and Ethinyl Estradiol Tablets 0.1 mg /0.02 mg and Ethinyl Estradiol Tablets 0.01 mg from the U.S. Food and Drug Administration (FDA) for the company’s Abbreviated New Drug Application (ANDA) to market a generic version of Teva Women’s Health, Inc’s. LoSeasonique® Tablets.

Lupin believes that it is one of the first applicants to file an ANDA for LoSeasonique® Tablets and will be entitled to 180 days of marketing exclusivity.

Commenting on the launch, Nilesh Gupta, group president of Lupin said, “We are very happy to receive this approval. This product approval demonstrates our commitment to deliver a quality Oral Contraceptive pipeline to consumers in the U.S., built around our development and vertically integrated manufacturing strengths. Consumers can be assured they are receiving quality products that they have been accustomed to, at a more affordable price”.

In the late afternoon, Lupin was trading at around Rs470.05 per share on the Bombay Stock Exchange, 0.85% down from the previous close.

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Hindustan Zinc to pay record Rs 736 crore dividend

The amount of interim dividend paid to Government of India is Rs187.19 crore

Vedanta Group firm Hindustan Zinc today said it will pay a record interim dividend and corporate dividend tax of Rs736.62 crore to the Government of India.

"The amount of interim dividend paid to Government of India is Rs187.19 crore. The total contribution by Hindustan Zinc to the government on account of interim dividend and corporate dividend tax would be Rs736.62 crore," the company said.

The Anil Agarwal-led firm claims to be the world's largest integrated producer of zinc and lead.

The Board of Directors of the company, in its meeting held on October 19, had declared interim dividend of 75% -- Rs1.50 per equity share of Rs2 each for the year 2011-12. The Government of India holds 29.53% equity shares in the company.

"Our partnership with the government continues to scale new heights. Not only do we run a robust business, but our partnership with the government for running sustainable and development projects ... Touches the lives of over half a million people across Rajasthan," Hindustan Zinc chairman Agnivesh Agarwal said.

The company had reported a 41.74% jump in its net profit to Rs1,344.69 crore for the quarter ended September 30, 2011, on the back of higher prices of zinc, lead and silver in international markets. It had reported a net profit of Rs948.72 crore for the same period a year ago.

Net sales of the company stood at Rs2,593.49 crore, registering a growth of 19.92% during the quarter under review from Rs2,162.88 crore in the July-September quarter of FY11.

During the quarter, the company's revenues from its refined zinc and lead businesses increased 12.21% to Rs2,320.31 crore, while its silver business reported a growth of over 120% to Rs239.39 crore.

In the late afternoon, Hindustan Zinc was trading at around Rs126.90 per share on the Bombay Stock Exchange, 0.94% down from the previous close.

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PAC meeting on 2G deferred amid sharp differences

The BJP and other opposition parties insisted that former DG (Audit) RP Singh should be summoned as he has differed with the figures of loss incurred by the government in the 2G scam. Mr Singh, who has now retired, has stated that the loss is merely of Rs6,000 crore while the CAG had maintained that it was to the tune of Rs1.76 lakh crore

New Delhi: The second generation (2G) spectrum controversy rocked the Parliament’s Public Accounts Committee (PAC) meeting here Monday with opposition parties demanding that former DG (Audit) RP Singh be summoned and asked why he differs with CAG on the quantum of loss while Congress members opposed the move, reports PTI.

With differences persisting, the meeting was adjourned.

The meeting scheduled for tomorrow has also been postponed reportedly on as Chhath festival falls Tuesday.

Sources said the BJP and other opposition parties insisted that Mr Singh should be summoned as he has differed with the figures of loss incurred by the government in the 2G scam. Mr Singh, who has now retired, has stated that the loss is merely of Rs6,000 crore while the CAG had maintained that it was to the tune of Rs1.76 lakh crore.

Prakash Javadekar (BJP) demanded that not only Mr Singh but others like telecom minister Kapil Sibal—who said there was zero loss- among others, should be summoned by the PAC and asked how they had arrived at figures different from that of the CAG. AIADMK member M Thambidurai insisted that the Central Bureau of Investigation (CBI) director should also be called as the agency had arrived at a different loss figure.

BJP, BJD, SAD and AIDMK referred to the letter written by Congress member Sanjay Nirupam asking that the 2G issue be discussed and said the questions which have not been addressed should be gone into.

Caught in a bind over Mr Nirupam’s letter, Congress members on Monday argued that Mr Singh cannot be asked to present his views in front of the CAG and his team—which is present in every PAC meeting—as he does not concur with them.

Some Congress members in the PAC were later heard saying that Mr Nirupam had caused an unnecessary hassle by writing this letter. The matter is now with the JPC and PAC could have avoided getting into the issue afresh.

Opposition members demanded that since Mr Singh has retired he has nothing to fear and so can freely depose before the PAC. One member even maintained that there have been several instances where those summoned by the committee have differed with the CAG.

With no consensus in sight, PAC chairperson Murli Manohar Joshi adjourned the meeting on the ground that the legal and constitutional aspects related to the issues raised by the members Monday will be looked into and then brought up for discussion at a later meeting.

RP Singh, who had come prepared to attend the meeting and make his presentation, was not called in on Monday.

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