Lannett Co. Inc. now has access to “the lion's share of the market” for newly approved dosage strengths of its hydrocodone bitartrate and acetaminophen tablets, following recent U.S. Food and Drug Administration authorization.
Previously marketed and acting as the therapeutic equivalent to Norco or Lortab products, new formulations will be produced subsequent to the company’s approved Abbreviated New Drug Application and are listed as 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg.
"The dosage strengths approved by this ANDA currently represent the lion's share of the market for Hydrocodone Bitartrate and Acetaminophen Tablets and complement our already approved strengths of 5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg," Lannett CEO Arthur Bedrosian said. "New product approvals are the growth engine of generic drug manufacturers.”
Bedrosian added that Lannett has attained five approvals thus far in 2017, including four approvals during June alone.
“These approvals expand our pain management franchise and increase the total number of products we offer to the marketplace,” he said. “We plan to launch all of our recently approved products in our new fiscal year … With a number of drug applications pending at the FDA, both our own filings and those of our alliance partners, we believe additional approvals are forthcoming."
Hydrocodone bitartrate is an opioid analgesic and antitussive.