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June 15, 2011

The Food and Drug Administration has issued a warning letter to Dr. Reddy’s Labs’ chemical manufacturing plant in Mexico, the company said Tuesday.

HYDERABAD, India — The Food and Drug Administration has issued a warning letter to Dr. Reddy’s Labs’ chemical manufacturing plant in Mexico, the company said Tuesday.

The drug maker said Dr. Reddy’s subsidiary Industrias Quimicas Falcon de Mexico, in Cuernavaca, received an FDA warning letter based on a November 2010 inspection where the regulatory agency found a number of manufacturing problems.

Dr. Reddy’s said it takes the warnings seriously and will respond to the FDA and work with the agency to resolve the problems.

June 7, 2011

Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

HYDERABAD, India — Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

The drug maker said that the FDA approved donepezil hydrochloride tablets, a generic version of Pfizer and Eisai's Arciept, in the 5-mg and 10-mg strengths for the treatment of Alzheimer's disease. Both strengths will be available in 30-, 90- and 500-count bottles.

June 6, 2011

The Food and Drug Administration has approved a dozen new generic versions of a drug used to treat breast cancer, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a dozen new generic versions of a drug used to treat breast cancer, the agency said Monday.

The FDA said that on Friday it approved versions of Novartis’ drug Femara (letrozole) made by Teva Pharmaceuticals USA, Dr. Reddy’s Labs, Sun Pharmaceutical Industries, Impax Labs, Endo Pharmaceuticals, Roxane Labs, Accord Healthcare, Synthon Pharmaceuticals, Natco Pharma, Indicus Pharma, Fresenius Kabi Oncology and Kudco Ireland.

March 30, 2011

Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

HYDERABAD, India — Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

The generic drug maker said it completed the acquisition of the facility and related product portfolio, including Augmentin and Amoxil brands. GSK will retain the existing rights for the aforementioned brands outside the United States.

Further financial terms and conditions of the transaction are not being disclosed.

March 21, 2011

Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.

NEW YORK — Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.

February 23, 2011

Generic drug maker Caraco Pharmaceutical Industries will merge with Sun Pharmaceutical Industries, Caraco said Tuesday.

DETROIT — Generic drug maker Caraco Pharmaceutical Industries will merge with Sun Pharmaceutical Industries, Caraco said Tuesday.

Sun, which already owns 75.8% of Caraco, will pay $5.25 per share for the remaining shares of Caraco that it doesn’t already own and make Caraco a private company.

Sun originally made the going private offer in December, offering $4.75 per share for Caraco.

February 18, 2011

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 1, 2011

A federal court has lifted an injunction that had prevented drug maker Dr. Reddy’s Labs from marketing a generic version of an allergy drug.

HYDERABAD, India — A federal court has lifted an injunction that had prevented drug maker Dr. Reddy’s Labs from marketing a generic version of an allergy drug.

Dr. Reddy’s said the U.S. District Court of New Jersey had filed a stipulation and order lifting the earlier injunction against the drug maker regarding the selling of a version of fexofenadine hydrochloride and pseudoephedrine hydrochloride tablets in the 180-mg/240-mg strength. The drug is a generic version of Sanofi-Aventis’ and Albany Molecular Research’s Allegra-D 24.

February 1, 2011

NEW YORK — The U.S. healthcare system could get at least $70 billion in savings over the next four years thanks to loss of patent protection for branded drugs, according to published reports.


IMS Health SVP Murray Aitken said at the Reuters Health Summit that generics also would increase their dominance in terms of prescriptions dispensed, increasing from 77% during the first half of this year to perhaps 85% by 2014, Reuters reported.


January 5, 2011

A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.

NEW YORK — A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.

Gurgaon, India-based Ranbaxy Labs plans to launch its version of Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin) in the United States in November and will receive six months’ market exclusivity in which to compete directly against Pfizer’s version, under the terms of the Hatch-Waxman Act of 1984.

December 22, 2010

Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.

DEERFIELD, Ill., and OSAKA, Japan — Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.

November 30, 2010

Ranbaxy Pharmaceuticals has received final approval for its generic Alzheimer's drug from the Food and Drug Administration, giving the drug maker 180 days of market exclusivity.

GURGAON, India, and PRINCETON, N.J. — Ranbaxy Pharmaceuticals has received final approval for its generic Alzheimer's drug from the Food and Drug Administration, giving the drug maker 180 days of market exclusivity.

Ranbaxy Pharmaceuticals, a subsidiary of Ranbaxy Labs, will manufacture and market donepezil hydrochloride tablets, a generic version of Aricept, in the 5-mg and 10-mg strength in the United States.

November 21, 2010

Indian generic drug maker Dr. Reddy’s Labs has launched a version of an asthma drug...

HYDERABAD, India Indian generic drug maker Dr. Reddy’s Labs has launched a version of an asthma drug for the U.S. market, the company said.

Dr. Reddy’s announced the launch of zafirlukast tablets in the 10-mg and 20-mg strengths. The drug is a version of AstraZeneca’s Accolate, which had sales of $50 million during the 12-month period ended in August, according to IMS Health.

November 14, 2010

The world of generic drugs has a big year ahead of it. Actually, it has...

The world of generic drugs has a big year ahead of it. Actually, it has a few big years ahead of it. But 2011 in particular carries a certain symbolic value as the year in which Pfizer, the world’s biggest drug maker, loses control of its patent for the cholesterol-lowering drug Lipitor (atorvastatin calcium), the world’s top-selling drug.

November 8, 2010

Loss of patent protection for branded drugs and subsequent competition from generics could save the...

NEW YORK Loss of patent protection for branded drugs and subsequent competition from generics could save the U.S. healthcare system $70 billion or more over the next four years, according to published reports.

 

Reuters reported IMS Health SVP Murray Aitken as saying at the Reuters Health Summit that generics also would increase their dominance in terms of prescriptions dispensed, increasing from 77% during the first half of this year to perhaps 85% by 2014.

 

 

October 4, 2010

Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug...

NEW YORK Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug made by Eisai, according to published reports.

Bloomberg reported Tuesday that the Indian drug maker had won 180 days’ exclusivity in which to market a generic version of Eisai’s Aricept (donepezil hydrochloride) tablets, pending final Food and Drug Administration approval, beating out Israel-based Teva Pharmaceutical Industries.

September 28, 2010

Sun Pharmaceutical Industries' subsequent offering period by one of its subsidiaries for all outstanding ordinary...

MUMBAI, India Sun Pharmaceutical Industries' subsequent offering period by one of its subsidiaries for all outstanding ordinary shares for drug maker Taro has expired, Sun Pharma said Wednesday.

Sun subsidiary Alkaloida Chemical Company Exclusive Group was informed that 29,382 ordinary shares of Taro had been tendered as of Tuesday. During the pendency of the subsequent offering period, no additional shares have been tendered. All tendered ordinary shares were accepted for payment.

August 11, 2010

The CEO of Ranbaxy Labs will step down next week, the Indian generic drug maker...

June 14, 2010

A U.S. District Court has granted French drug maker Sanofi-Aventis and Albany Molecular Research an...

June 9, 2010

The Food and Drug Administration has given tentative approval to Dr. Reddy’s Labs for a...

May 20, 2010

Dr. Reddy’s Labs has launched a treatment for organ transplant patients, the Indian generic drug...

May 11, 2010

Ranbaxy Labs had net sales of $542 million and profits of $210 million in first...

March 14, 2010

India’s Ranbaxy Labs will launch a generic version of a diabetes drug in two years,...

January 18, 2010

Ranbaxy Labs has made a foray into the world of vaccines, the generic drug maker...

January 4, 2010

An India-based drug maker said its investigational drug for treating diabetes met its goals in...