Lannett Receives FDA Approvals For Two Products

March 29, 2016: Lannett Company, Inc receives FDA approvals for two products. Lannett Company, Inc. announced it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Potassium Chloride Extended-release Capsules USP, 8 mEq and 10 mEq, the therapeutic equivalent to the reference listed drug of Actavis Labs FL, Inc., and Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug TemodarCapsules of Merck & Co.

According to IMS, total U.S. sales in 2015 of Potassium Chloride Extended-release Capsules USP, 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) were approximately $89 million and $206 million, respectively.

More Lannett News

February 22, 2016: Lannett Company, Inc. announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray, the therapeutic equivalent to the reference listed drug ImitrexNasal Spray, of GlaxoSmithKline. According to IMS, total U.S. sales in 2015 of Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray at Average Wholesale Price (AWP) were approximately $62 million.

February 11, 2016: FDA approves Lannett Company’s Temozolomide capsules. Lannett’s wholly owned subsidiary, Kremers Urban Pharmaceuticals Inc., has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug TemodarCapsules of Merck & Co. According to IMS, total U.S. sales in 2015 of Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg at Average Wholesale Price (AWP) were approximately $206 million.

November 19, 2015: Lannett Company (LCI Updated Trend Analysis) Roth Capital reiterates Buy rating, price target $47. Roth says the October monthly prescription data from Wolters Kluwer was recently released. Roth analyst says the data is in-line to slightly ahead of expectations due to stable market share so far in 2015. Roth believes pricing power has been maintained in the digoxin category, but indicates the focus is now on new competition from Mylan, Par, Hikma, and Sun.

October 14, 2015: Lannett Company receives FDA approval for Memantine Hydrochloride oral solution, 2 mg/mL Announced that its wholly owned subsidiary, Silarx Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Memantine Hydrochloride Oral Solution 2 mg/mL, the therapeutic equivalent to the reference listed drug NamendaOral Solution, 2 mg/mL of Forest Pharmaceuticals. According to IMS, for the year ended June 2015 total sales of Memantine Hydrochloride Oral Solution 2 mg/mL at Average Wholesale Price (AWP) were approximately $12 million.

September 3, 2015: Roth Capital reiterates Buy rating, price target $68. Roth analyst likes that LCI announced a transformative acquisition of Kremers Urban Pharmaceuticals for $1.23B in cash. This deal could potentially double the revenue base and be accretive to 2016/17 EPS targets (20-25% in 2017).

Lannett Company (LCI Updated Trend Analysis), founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. The company offers solid oral, extended release, topical, nasal, and oral solution finished dosage forms of drugs that address a range of therapeutic areas, as well as ophthalmic, patch, foam, buccal, sublingual, soft gel, and injectable dosages.

Follow me

Lance Jepsen

For ethical purposes, I try not to hold any position in any stock I profile on GuerillaStockTrading.com unless specifically stated in the article. Owner of GuerillaStockTrading.com. Seasoned entrepreneur, investor, and writer. I love God, family, country, stock trading, economics, and helping people learn how to trade.
Follow me

Author: Lance Jepsen

For ethical purposes, I try not to hold any position in any stock I profile on GuerillaStockTrading.com unless specifically stated in the article. Owner of GuerillaStockTrading.com. Seasoned entrepreneur, investor, and writer. I love God, family, country, stock trading, economics, and helping people learn how to trade.

Leave a Reply