COLUMBUS, Ohio, June 18 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Ramipril Capsules, 1.25mg, 2.5mg, 5mg and 10mg by the U.S. Food and Drug Administration. The 1.25mg, 2.5mg, 5mg and 10mg strengths will be available in various packaging configurations. Roxane Laboratories Ramipril Capsules are available for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories' Ramipril Capsules are AB rated to ALTACE(R) (ramipril) Capsules. Annual sales of Ramipril Capsules, 1.25mg, 2.5mg, 5mg and 10mg are approximately $932 Million(1).
Roxane Laboratories' Ramipril capsules are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
Please refer to the full prescribing information for a list of the most commonly reported side effects.
Full prescribing information for Ramipril Capsules is available on the Roxane Laboratories website at http://www.Roxane.com or upon request by calling Roxane Laboratories Technical Product Information at 1.800.962.8364.
About Roxane Laboratories, Inc.
Roxane Laboratories is located in Columbus, OH in a modern 500,000 square foot manufacturing and laboratory facility. The facility spans 70 acres and currently employs over 1,000 people. Currently, Roxane Laboratories markets over 75 medications in nearly 250 package sizes, focusing on an expanding line of Multisource pharmaceutical products including: bulk and unit-dose liquids and solids; coated, sustained-release and controlled-release tablets; nasal sprays, cytotoxics and CII narcotics.
Roxane Laboratories, Inc., is a subsidiary of Boehringer Ingelheim
Corporation, based in Ridgefield
|SOURCE Roxane Laboratories, Inc.|
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