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Able Laboratories Receives FDA Approval for Lithium Carbonate Capsules
SOUTH PLAINFIELD, N.J., June 29 /PRNewswire-FirstCall/ -- Able Laboratories, Inc. , today announced that it has received Food and Drug Administration approval for its Abbreviated New Drug Applications for Lithium Carbonate Capsules, USP 150mg, 300mg and 600mg, which are therapeutically equivalent to Lithium Carbonate Capsules, USP 150mg, 300mg and 600mg, of Roxane Laboratories, Inc. The incremental total sales for Able's newly approved 150mg and 600mg capsules (used in the treatment of manic episodes of bipolar disorder), is estimated to be approximately $2 million according to recent market data.
Able currently markets Lithium Carbonate Capsules, USP 300mg which represents the majority of the total sales in this product category. This approval represents the expansion of Able's line of Lithium-based products.
Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Further information on Able may be found on the Company's web site, http://www.ablelabs.com/.