PHARMACY

Spring sports physicals now available at MinuteClinic

BY Antoinette Alexander

WOONSOCKET, R.I. — MinuteClinic announced that it is offering spring sports physicals at its facilities across the country to make it easier and more affordable for children and teenagers to head to the field and participate in organized sports.

Beginning March 1 to 31, MinuteClinic will offer the pre-participation physicals, which are required by many states, school systems and athletic leagues. MinuteClinic nurse practitioners and physician assistants will offer the exams seven days a week, including weekday evenings. No appointment is necessary.

Coaches, team leaders and athletic directors also can take advantage of an additional $5 team discount.

Once a child is cleared to play, MinuteClinic practitioners will stamp any required forms and reference the results provided on the official patient summary. Copies of the summary can be transmitted by electronic record, fax or mail to a primary care provider with patient permission.

In addition to sports physicals, MinuteClinic offers camp, college and Department of Transportation physicals on a daily basis at about 500 select CVS/pharmacy locations around the country.

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Endo launches Fortesta

BY Alaric DeArment

CHADDS FORD, Pa. — Endo Pharmaceuticals has launched a recently approved testosterone gel for men.

Endo announced Thursday the launch of Fortesta, approved by the Food and Drug Administration for treating low testosterone — or low T — in men, which affects about 14 million men in the United States; around 1.3 million of those men currently are receiving treatment, according to Endo.

“We are excited to bring Fortesta gel to market in the United States and are confident that once men try it, Fortesta gel will quickly become a significant treatment option for many men with low T,” Endo COO Julie McHugh said.

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Merck receives CRL for MS treatment

BY Allison Cerra

DARMSTADT, Germany — The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

The drug maker said it received a complete response letter from the FDA on Wednesday for cladribine tablets, Merck’s proprietary investigational oral formulation of cladribine. The regulatory agency noted in the CRL that Merck did provide substantial evidence of cladribine tablets’ effectiveness in its CLARITY1 study, but requested Merck provide an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies.

“Our commitment to transform the way people living with MS approach their therapy options remains steadfast,” said Fereydoun Firouz, president and CEO of Merck’s U.S. subsidiary, EMD Serono. “We look forward to working with the FDA to address the safety issues in its letter and will continue to move toward identifying a potential path that provides patients and physicians the opportunity to have access to cladribine tablets in the treatment of MS.”

Cladribine tablets are approved and available under the trade name Movectro in Australia and Russia as a treatment of relapsing-remitting MS. Merck noted the tablets also are under regulatory review in other countries.

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