Approvals

Anti-diarrheal Treatment for HIV/AIDS Patients Attains Approval

Fulyzaq is indicated for relief of symptoms in patients taking antiretroviral therapy to treat HIV infection.

The U.S. Food and Drug Administration today approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.

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Perrigo Announces FDA Approval Of Betamethasone Valerate Foam 0.12%

The product, from the company’s partner firm Cobrek Pharmaceuticals Inc., is indicated for treatment of scalp psoriasis.

Perrigo Co. announced that its partner, Cobrek Pharmaceuticals, Inc., received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for betamethasone valerate foam 0.12%, the generic equivalent of Luxiq Foam. Perrigo has manufactured the product and is preparing to commence commercial shipments on January 15, 2013, consistent with the date certain launch settlement. Cobrek was first to file, making the product eligible for 180 days of marketing exclusivity.

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GSK, Theravance Attain Approval for New COPD Treatment

The FDA has approved the new drug application for a once-daily medication for patients with chronic obstructive pulmonary disease.

GlaxoSmithKline plc (GSK) and Theravance, Inc. today announced that the New Drug Application (NDA) for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" (FF/VI) for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the US Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has also been confirmed as 12 th May 2013.

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FDA Approves New Weight-loss Pills

Diet Doc claims its Ultra Burn and Slim Down promote rapid, effective weight loss.

FDA approved weight loss pills launched by Diet Doc promote effective and fast weight loss compared to other diet pills in the market.

The new, approved diet pills from Diet Doc promote rapid and effective weight loss when compared to other clinical studies of diet pills in the market. The two new weight loss pills launched by the company are Ultra Burn, a fast acting and safe fat burner and Slim Down, an appetite suppressant and lipotropic (fat burner).

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FDA Approves New Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.
 
People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
 

European Commission Approves Orencia

European Commission Approves Orencia in Combination with Methotrexate for Earlier Use as First-Line Biologic after DMARD Inadequate Response for the Treatment of Rheumatoid Arthritis

 

European Commission Approves ORENCIA in Combination with Methotrexate for Earlier Use as First-Line Biologic after DMARD Inadequate Response for the Treatment of Rheumatoid Arthritis

 

•Data show ORENCIA offers durable and sustained long-term efficacy

FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film

PR Newswire US - Jul. 02, 2010

WOODCLIFF LAKE, N.J., July 2 /PRNewswire/ -- Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.

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