Corporate News Blog – Lannett Receives Approval for Additional Dosage Strengths of Hydrocodone Bitartrate and Acetaminophen Tablets USP

LONDON, UK / ACCESSWIRE / June 28, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Lannett Co., Inc. (NYSE: LCI), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=LCI. The Company announced on June 26, 2017, that it has received approval from the US Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg; the therapeutic equivalent to the reference drug, Norco tablets, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg, of Allergan Pharmaceuticals International Limited. The product is also known under the brand name, Lortab, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg. For immediate access to our complimentary reports, including today’s coverage, register for free now at: http://protraderdaily.com/register/.

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Hydrocodone Bitartrate and Acetaminophen Tablets

This drug is administered in the form of a tablet, through an oral intake. Hydrocodone Bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. Acetaminophen, on the other hand, is a slightly better, white, odorless, crystalline powder, non-opiate, non-salicylate analgesic and antipyretic.

Effects

Hydrocodone is a semisynthetic narcotic analgesic with multiple actions, similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is still ambiguous, but it is believed to relate to the existence of opiate receptors in the CNS. On the other hand, the analgesic action of acetaminophen involves peripheral influences, with the specific mechanism still undetermined. Acetaminophen inhibits prostaglandin synthetase and has a negligible effect on the cardiovascular and respiratory systems.

Dosage Strength

The dosage strength currently approved by the ANDA represent the primary share of the market for Hydrocodone Bitartrate and Acetaminophen Tablets, and complements the previously approved strengths of 5mg/300 mg, 7.5mg/300 mg, and 10mg/300 mg. Prior to the announcement, on June 22, 2017, the Company announced that it has received an approval from the FDA for its ANDA application concerning Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, the therapeutic equivalent to the reference standard drug, the Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, of Mikart, Inc.

Lannett Growth Prospects

This approval from the FDA, for the Hydrocodone Bitartrate and Acetaminophen Tablets, is viewed as an important and valuable combination drug product for the pain management franchise. The Company received the first approval from the FDA of its ANDA for Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, on September 14, 2012, initially, where according to the Company, the sale of these three products, climbed 5% y-o-y for the last three years.

Lannett Co., founded in 1942, deals in development, manufacturing, packaging, marketing, and distribution of generic pharmaceutical products for a wide range of medical indications. Lannett views this approval as a significant milestone, complementary to the two other recently approved ANDAs. The Company expects these approvals to benefit FY18 revenues, while it has 20 more drug applications pending at the FDA, and believe additional approvals will follow this recent announcement.

Last Close Stock Review

On Tuesday, June 27, 2017, the stock closed the trading session at $20.50, marginally down 0.97% from its previous closing price of $20.70. A total volume of 472.95 thousand shares have exchanged hands. Lannett’s stock price advanced 2.24% in the last one month. The stock currently has a market cap of $734.72 million.

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