A Canadian-made drug company says its drug product will be made in India by Indian manufacturers after testing and regulatory approval in the US.
The company said it had received an application for the product from the US Food and Drug Administration for production of a novel formulation of sildenafil citrate, a drug used to treat erectile dysfunction, and a generic version of Viagra.
The application was approved in the US by the Food and Drug Administration, on June 3, 2013.
The company has received regulatory approval for the development and production of the generic version of the drug Viagra and has submitted it for approval in the US. Sildenafil is a generic drug used to treat erectile dysfunction.
India has an estimated 10,000 employees, and it is the largest drug industry in the world. The company's patent expired in the US in 2013, and its US headquarters were in Montreal, Quebec.
The Canadian company, which develops and manufactures drugs for the US market, has been in talks with some Indian drug companies about developing the generic version of the drug Viagra.
A company spokesperson said the company had received the application for the generic version of the drug, which is now available in the US.
Dr. Mohit Bishar, CEO of Dr. Bhushan India Ltd., told TOI: "The company has received a regulatory application for production of Viagra and has submitted a request for approval in the US. We have received the application."
A Canadian company, known as Dr. Akansan Ltd., has also been working on the generic version of the drug.
The company said it had received an application for the generic version of the drug, which is now available in the US.
Bhushan India Ltd. said in a statement, "We have received the application for the generic version of Viagra. Our goal is to develop a new drug that has an identical therapeutic effect and safety profile to the existing drug."
It said the company has received a finalised application for the generic version of the drug, which has been submitted for approval in the US. It has also been in the process of working on the generic version of the drug.
In September, the Canadian drug giant had received an application for the generic version of the drug, which is now available in the US.
The company said it was aware of the Indian pharmaceutical company's interest in developing the drug.
Akansan, the company's general manager, said in a statement that the company had received an application for the generic version of the drug.
In July, the company was in talks with the Indian manufacturer of the drug and had been able to produce the drug for its US headquarters in Canada.
India has been the first US company to make a drug in India. It is the largest drug industry in the world. India's first drug is the generic version of the drug.
The drug was approved by the FDA in March, and it has been in the market since then.
The US company was also approved by the FDA in July in the form of an injection, in order to manufacture the drug.
Bhushan's spokesperson told TOI: "The company has received an application for the generic version of Viagra. We have received the application for the generic drug. We are very interested in the potential application."
The Canadian drug giant had received an application for the generic version of Viagra, which is now available in the US.
Akansan was a former Canadian doctor. He has worked at several companies, including Pfizer, Eli Lilly and Bristol-Myers Squibb.
In January, the company received a request for approval for the generic version of the drug, which is now available in the US.
The company's application was filed for production of the generic version of the drug, which is now available in the US. The company said the drug is ready to be used for its US patent.
The Indian company, Dr. Akansan, has been in talks with some Indian drug companies about developing the generic version of the drug.
In a letter to TOI, Dr. Akansan's spokesperson said the company had received an application for the generic version of the drug and was ready to supply it to the US.
The drug's manufacturer, Pfizer, says the Food and Drug Administration has warned consumers about the drug's use for an enlarged prostate. The company says the condition is a common side effect of some medicines, and that there are no "black box" warnings or precautions.
The FDA's warning, in its statement, said the drug is not approved for use in the treatment of erectile dysfunction, a condition where a man cannot get or keep a hard, erect penis suitable for sexual activity.
In March, a study showed that patients with an enlarged prostate who took Viagra had an average of 3.4 times as many problems with achieving or maintaining an erection as those who took a placebo. The study was a follow-up study, but it was not definitive on whether Viagra could help with erectile dysfunction.
Viagra, Pfizer's erectile dysfunction drug, is sold as a generic version.
The company says it has no plans to change its warning label or the way it uses the drug. However, it said that a spokeswoman for Pfizer, Pfizer's patent-protected company, would be happy to provide information on the side effects of the drug, including whether the drug is safe for patients to take.
The company told The Associated Press the drug is still under patent and that the FDA is still reviewing the issue.
Image: The New York TimesOriginally Published: March 14, 1998 at 12:00 AM EDT
The FDA says Viagra may help with erectile dysfunction. The drug was the first FDA-approved for the treatment of the disease in 1998. (AP Photo/Shawn 1918, jane.wikipedia.org) -- U. S. Food and Drug AdministrationOriginally Published: March 14, 1998 at 1:00 PM EDTU. Food and Drug Administration The Food and Drug Administration said that its warning about the use of Viagra is based on its analysis of a study that found that men who took the drug for more than four months had higher rates of erectile dysfunction than those who did not take the drug.A spokesman for Pfizer said he did not know how many patients had erectile dysfunction, but had taken the drug at least four months before the study was completed. He said the company was "playing by the rules" and that patients were not being given a placebo.
The company said the FDA does not have "an open and ready" position on Viagra, but it said the company will update its information once the drug is approved. It said Viagra was available in generic form under the name Revatio, and that generic drugs are not available in the United States.
Image: The Associated PressOriginally Published: March 14, 1998 at 3:00 PM EDT
The agency is warning about Viagra's possible link to a heart attack or stroke. (AP Photo/Shawn 1819, jane.wikipedia.org) -- U.In May, a study showed that men who took Viagra for more than four months had a greater likelihood of developing erectile dysfunction, and that there was no difference in rates between the two groups.The FDA says Pfizer is not sure what the drug might do to treat erectile dysfunction. The company said it was not aware of any risks.The drug is the first FDA-approved for the treatment of the disease. The drug is sold as a generic version of Viagra.
The company said it is "playing by the rules" and that the FDA is still reviewing the issue.
The agency is also looking into whether the drug could help patients with diabetes, high blood pressure, or high cholesterol. The drug, which is used to treat high blood pressure, was approved by the U. Food and Drug Administration in November. The FDA does not approve drugs for diabetes or high blood pressure.
The FDA said that some patients with diabetes may be taking the drug for erectile dysfunction.
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More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
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