Albuterol Sulfate and Ipratropium Bromide
Teva announced today that the USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Dey's bronchodilator, DuoNeb(R) (Albuterol Sulfate and Ipratropium Bromide) Inhalation Solution, 3 mg (0.083%) and 0.5 mg (0.017%). Shipment of the product will begin immediately.
The brand product had annual sales of approximately $265 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
Granisetron hydrochloride
Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s Kytril (granisetron hydrochloride) Tablets, 1mg (eq to 1 mg base). The Company received final approval following the expiration of Roche's patent on December 28, 2007, and plans to launch its product shortly.
KYTRIL (granisetron hydrochloride) Tablets, 1 mg (eq to 1 mg base) is indicated for the prevention of: nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin; and, nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. The product had annual sales of approximately $88 million for the twelve months ended October 2007, based on IMS sales data
Teva announced today that the USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Dey's bronchodilator, DuoNeb(R) (Albuterol Sulfate and Ipratropium Bromide) Inhalation Solution, 3 mg (0.083%) and 0.5 mg (0.017%). Shipment of the product will begin immediately.
The brand product had annual sales of approximately $265 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
Granisetron hydrochloride
Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s Kytril (granisetron hydrochloride) Tablets, 1mg (eq to 1 mg base). The Company received final approval following the expiration of Roche's patent on December 28, 2007, and plans to launch its product shortly.
KYTRIL (granisetron hydrochloride) Tablets, 1 mg (eq to 1 mg base) is indicated for the prevention of: nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin; and, nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. The product had annual sales of approximately $88 million for the twelve months ended October 2007, based on IMS sales data
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