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FDA approves Amneal Pharmaceuticals’ ANDA for atovaquone oral suspension

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration last week approved Amneal Pharmaceuticals’ abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL. 

Atovaquone is the generic equivalent of GlaxoSmithKline’s Mepron, indicated for the prevention of Pneumocystis jiroveci pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.

Pneumocystis jiroveci pneumonia is a fungal infection of the lungs in people with a weakened immune system due to cancer, chronic use of corticosteroids or other medications that weaken the immune system, HIV/AIDS or organ or bone marrow transplant. 

 

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Upsher-Smith sells women’s health portfolio to Vertical Pharmaceuticals

BY Michael Johnsen

MAPLE GROVE, Minn. — Upsher-Smith Laboratories on Monday announced that it has entered into a definitive agreement under which New Jersey-based Vertical Pharmaceuticals has acquired Upsher-Smith’s rights to Divigel (estradiol gel) 0.1%, Nexa Plus Rx Prenatal Vitamin, and Provella, a probiotic dietary supplement. As part of the transaction, Upsher-Smith has transferred the new drug application for Divigel to Vertical Pharmaceuticals. 

"We are pleased to reach this agreement with Vertical Pharmaceuticals, a company that is strategically focused on women’s health," stated Mark Evenstad, president and CEO Upsher-Smith. "We are excited to drive our base business forward and pursue our strategic objective of providing therapies that empower people living with [central nervous system] conditions to lead healthy, productive lives through our commercial and developmental efforts."

Divigel is indicated for the treatment of moderate to severe hot flashes due to menopause.

Additional terms related to the deal have not been disclosed. Mizuho Securities served as exclusive adviser to Upsher-Smith on this transaction.

 

 

 

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LA Times: Covered California exchange to promote ACA at CVS/pharmacy, Ralphs

BY Antoinette Alexander

LOS ANGELES — As the March 31 enrollment deadline draws near, CVS/pharmacy and Ralphs grocery chain have inked deals with the Covered California exchange to promote the healthcare law inside their retail outlets, the Los Angeles Times has reported.

As previously reported by Drug Store News, CVS/pharmacy, through a strategic partnership with Humana, has been providing information on the Affordable Care Act in its stores since the enrollment period opened in October.

According to the LA Times, the Covered California exchange will provide additional information in 120 CVS stores in areas with the highest concentration of residents who are eligible for federal premium subsidies.

At Ralphs, shoppers can pick up brochures and other information. There will be in-store announcements and messages on receipts about health coverage, the article stated.

 

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