Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Ramipril capsules, 1.25 mg. 2.5 mg, 5 mg and 10 mg. Commercial shipments of the product have commenced.
Lupin's Ramipril capsules are the AB-rated generic equivalent of King Pharmaceutical's Altace(R) capsules, indicated for the treatment of hypertension. The brand product had annual sales of approximately $920 million for the twelve months ended December 2007, based on IMS Health sales data.
On June 5, 2008, in an effort to restrict Lupin's launch, King filed a motion for a temporary restraining order (TRO) and preliminary injunction against Lupin Pharmaceuticals, Inc. The hearing occurred June 10, 2008 and King's motion was denied.
The details can be read here.
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