Lupin gets tentative USFDA approval for diabetes drug

Lupin has received tentative approval from the US health regulator for its generic Metformin Hydrochloride extended-release tablets, used in the treatment of diabetes, in the US market

Drug maker Lupin has received tentative approval from the US health regulator for its generic Metformin Hydrochloride extended-release tablets, used in the treatment of diabetes, in the American market.

The company's US arm Lupin Pharmaceuticals Inc has received approval from the US Food and Drug Administration for Metformin Hydrochloride extended-release tablets in the strengths of 500mg and 1,000mg, Lupin said in a statement.

The company's product is generic equivalent of Andrx Labs LLC's Fortamet 500mg and 1,000mg tablets and is indicated as a supplement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, it said.

Lupin Pharmaceuticals CEO Vinita Gupta said: "This product approval demonstrates our commitment to enhance our generic pipeline, leveraging our development and manufacturing strengths in extended-release dosage forms."

The company believes it is the first applicant to file an abbreviated new drug application for Fortamet 500mg and 1,000mg and that could translate into 180 days of marketing exclusivity for its product.

"Upon receiving final approval by the FDA, Lupin believes that the 500mg and 1,000mg strengths of its product will be entitled to 180 days of marketing exclusivity," it said.

As per IMS Health data, annual sales for Fortamet in the US stood at $83 million for the 12 months ending December 2010, it added.

On Wednesday, Lupin ended 2.06% up at Rs416.25 on the Bombay Stock Exchange, while the benchmark Sensex gained 1.83% to 19,470.98.

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10% growth not feasible, 12th Plan to target 9-9.5% GDP: Montek

Prime minister Manmohan Singh wants the Commission to aim at higher growth target of 10% during the 12th Plan, as against 8.2% estimated in the current Plan

New Delhi: Raising doubts over the feasibility of achieving 10% average economic expansion in the 12th Plan (2012-17), Planning Commission deputy chairman Montek Singh Ahluwalia today said the next plan would target gross domestic product (GDP) growth of 9% to 9.5% in the next five years, reports PTI.

"If you ask me personally, I think setting target of 10% (GDP growth) as an average for 12th Plan, is not feasible...it would be somewhere between 9% to 9.5% in the next Plan period," he told reporters ahead of the meeting of the full Planning Commission.

Prime minister Manmohan Singh wants the Commission to aim at higher growth target of 10% during the 12th Plan, as against 8.2% estimated in the current Plan.

"Our assessment is that the international situation is full of uncertainty... I feel that if we are looking at a five year period (2012-17), we can do much better than we did in the 11th Plan. I don't think that there should be much difficulty setting a target of 9%," he said.

A major area of focus would be on increasing agricultural productivity, he added.

"In the 10th Plan it (agricultural growth) was around 2%, in the 11th Plan it looks as if it will be 3%... It won't be 4% that we had targeted. My view would be that in the 12th Plan we must make sure that we can get to 4%," Mr Ahluwalia said.

Briefing media persons on the focus of the full Planning Commission meeting tomorrow to be headed by the prime minister, Mr Ahluwalia said, "We would be presenting key issues to the full panel and the approach to the 12th Plan may be ready in a month from now."

Among others, the meeting will be attended by Planning Commission members and senior Cabinet ministers, including finance minister Pranab Mukherjee and home minister P Chidambaram.

"What we are presenting tomorrow is not the 12th Plan approach. We are actually working on that... The Approach Paper should be in a month or so," Mr Ahluwalia said. The 'Approach Paper' lays broad outline of a Five Year Plan.

About the thrust of the 12th Plan, he said, "One thing we have all agreed (internally at Plan panel) is that it (thrust of 12th Plan) will be faster, more inclusive and sustainable growth."

He also said that special thrust will be on achieving more progress in health and education, besides improving the gender ratio.

Regarding the progress of the 11th Plan, he said, "The bottom line is that we have seen progress but not enough."

Although the Commission had pegged the economic growth rate at 9% for the 11th Plan (2007-12), it was scaled down to 8.2% in view of the impact of the global financial meltdown on the Indian economy.

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Gold crosses Rs22K mark, silver shines bright at Rs66,300

In international markets, gold climbed 0.3% to $1,500.43 an ounce and silver jumped 0.9% to a 31-year peak of $44.35 an ounce

New Delhi: Gold crossed the psychological level of Rs22,000 today on aggressive buying by stockists, amid a rising global trend. It rose by Rs115 to Rs22,060 per 10 grams. Silver also climbed to a new high, rising by Rs1,850 to Rs66,300 per kg on rising demand from industrial units, reports PTI.

Silver coins followed suit and shot up by Rs1,500 to a record high of Rs72,000 for buying and Rs72,500 for selling of 100 pieces.

Trading sentiments remained bullish as gold extended its record-making rally to top $1,500 an ounce in global markets as dollar fell on mounting debt in Europe and the US, prompting investors to seek bullion as a store of value.

In international markets, gold climbed 0.3% to $1,500.43 an ounce and silver jumped 0.9% to a 31-year peak of $44.35 an ounce.

Besides, retail customers and jewellers buying for the coming marriage season further fuelled the uptrend.

On the domestic front, gold of 99.9% and 99.5% purity shot up by Rs115 each to a new high of Rs22,060 and Rs21,940 per 10 grams, respectively.

Sovereigns also moved up by Rs100 to fresh peak level of Rs18,000 per piece of eight grams.

Silver continued its record setting spree and spurted by Rs1,850 to new peak level of Rs66,300 per kg and weekly-based delivery by Rs1,530 to Rs65,055 per kg.

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