Lannett has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg. The two dosage strengths of BAC Capsules, have a combined estimated IQVIA market value of approximately $68.6 million for the 12 months ending October 2019, although actual generic market values are expected to be lower.
"We have commenced marketing both dosage strengths of our newly approved BAC Capsules," said Tim Crew, chief executive officer of Lannett. "Thus far in fiscal 2020, we have launched about half a dozen products, among them are Posaconazole, Prednisone and Cyproheptadine, and we expect to launch as many as 12 products in the coming six months."
BAC Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg are the therapeutic equivalents of the reference listed drugs BAC Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg of Nexgen Pharma, Inc. and Mayne Pharma Inc., respectively.