Content about Sildenafil

NEW YORK - Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

State health authorities sent cease-and-desist letters to 11 pharmacies, telling 10 to stop compounding altogether and one to stop compounding the drug sildenafil citrate. Twenty-one other pharmacies were allowed to continue compounding, but were cited for minor violations.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

Mylan announced the FDA approval of sildenafil citrate tablets in the 20-mg strength, a generic version of Pfizer's Revatio. The drug is used to treat adults with PAH to improve exercise ability and delay clinical worsening of the condition.

Revatio had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

SILVER SPRING, Md. — In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products and removal of offending websites.

QUERENBURG, Germany — According to research to be published in the journal Circulation released Friday, sildenafil, the active ingredient in Viagra, can help alleviate heart problems.

The research was conducted in collaboration with the Mayo Clinic in Rochester, Minn.

NEW YORK — Pfizer announced that the patent for its popular erectile dysfunction treatment was upheld in court.

The drug maker said that the U.S. District Court for the Eastern District of Virginia concluded that Pfizer's patent for Viagra was valid and enforceable and prevents generic drug maker Teva from marketing its version of the drug until October 2019. Pfizer noted that litigation on the same patent remains pending against other generic companies, but no trials are scheduled in those other cases.

The court's decision, however, is subject to appeal by Teva.

HOLLYWOOD, Fla. — Global Wellness on Tuesday initiated a voluntary nationwide recall of its Via Extreme ultimate sexual enhancer dietary supplement for men.

The product — a bottle containing six blue-colored capsules per package — was distributed throughout the United States, Puerto Rico and Canada to Internet and retail consumers, the company reported.

Global Wellness is recalling only lots 809013 and 806030; the recall does not affect sales and distribution of Slim Extreme Gold and Gelslim, the company stated.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

The counterfeit product looks similar to the actual product, but either contains tadalafil, or a combination of tadalafil and sildenafil, all active ingredients in FDA-approved prescription medicines for erectile dysfunction.

MONROVIA, Calif. — Biotab Nutraceuticals on Tuesday initiated a voluntary recall of two lots of Extenze nutritional supplement tablets.

Some packages bearing lot numbers 0709241 and 0509075 are counterfeit products containing undeclared drug ingredients that can pose a serious risk to health, the company stated.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

SALT LAKE CITY Prolatis earlier this week announced a voluntary nationwide recall of the company’s product sold under the brand name Prolatis’ after being informed by the Food and Drug Administration that lab analysis has found their male-enhancement products to contain sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction.

That makes Prolatis’ an unapproved drug, as opposed to a dietary supplement.

NEW YORK What’s really intriguing behind the return of a consumer division to Pfizer is the fact that two of its flagship pharmaceuticals -- Lipitor and Viagra -- are approaching patent expiration, and both have been suggested as possible Rx-to-OTC switch candidates by Kline & Co.