Content about PDE5 inhibitors

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

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. — The Food and Drug Administration on Wednesday identified three online products touting "natural" intimacy enhancement that consumers should avoid because they each contain undeclared pharmaceutical ingredients.

The three products include Boost ultra sexual enhancement formula, VMaxx Rx and Firminite.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

The FDA announced the approval of Vivus' Stendra (avanafil).

"This approval expands the available treatment options to men experiencing erectile dysfunction and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," FDA Office of Drug Evaluation III deputy director Victoria Kusiak said.

NEW YORK — Last year, U.S. Customs and Border Protection seized $5.6 million worth of illegal pharmaceutical products, a 170% increase over 2005. Meanwhile, global sales of counterfeit medicines were estimated to be more than $75 billion last year, 90% more than in 2005.

In response, Pfizer and the National Association of Boards of Pharmacy announced Thursday the launch of an effort to educate patients on how to safely buy medicines online and about the risks of counterfeit drugs.

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.