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PHILADELPHIA — Lannett Co. has received Food and Drug Administration approvals for a pair of new generic products.
Abbreviated New Drug Applications (ANDAs) have been approved for potassium chloride extended-release capsules, in strengths of 8 mEq and 10 mEq, and for temozolomide capsules, in dosages of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, Lannett said Tuesday.
The potassium chloride ER capsules, used for preventing or treating low blood potassium levels, are a generic version of the reference listed drug of Actavis, according to Lannett. The temozolomide capsules are a generic equivalent of Merck’s Temodar capsules, an oral chemotherapy drug.
“The potassium chloride product represents the second approval received from our acquisition of Kremers Urban (KU),” stated Arthur Bedrosian, chief executive officer of Lannett. “This is our second approval for temozolomide, a product for which our KU subsidiary also recently received FDA approval and the only drug candidate in the pipelines of both Lannett and KU. We expect to launch temozolomide within the next few months and are evaluating launch options for our potassium chloride product.”
U.S. sales of potassium chloride ER capsules (8 mEq and 10 mEq) and temozolomide Capsules (5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg) at average wholesale price (AWP) totaled about $89 million and $206 million, respectively, in 2015, according to IMS Health figures cited by Lannett.
