Featured Company News Lannett Announces Approval for Amantadine - KFVS12 News & Weather Cape Girardeau, Carbondale, Poplar Bluff

Featured Company News Lannett Announces Approval for Amantadine Hydrochloride Capsules USP, 100 mg; Set to Launch Before the Flu Season

LONDON, UK / ACCESSWIRE / June 19, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Lannett Co., Inc. (NYSE: LCI). The Company announced on June 16, 2017, that it has received approval from the US Food and Drug Administration (FDA) for Amantadine Hydrochloride Capsules USP, 100 mg, of Sandoz Pharmaceuticals. The product was initially branded and marketed as Symmetrel® Capsules, 100 mg. According to IMS, net US sales of Amantadine Hydrochloride Capsules USP, 100 mg, at an Average Wholesale price for the 12-month period, ended April 2017, was about $25 million. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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The Announcement

Lannett finds this agreement too late to be accretive to FY17 which is set to end in June 2017 and plans to launch the product as per the upcoming flu season, while the Company expects additional product approvals. Arthur Bedrosian, CEO, Lannett, commented that the Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride Capsules was approved within 15 months, where the bioequivalency test was performed, at its wholly owned pharmacokinetic subsidiary, DarmanTest Laboratories.

Amantadine Hydrochloride Capsules are indicated for patients suffering from prophylaxis treatment of signs and symptoms of infection caused by different strains of influenza A virus. These capsules are also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions. Amantadine Hydrochloride Capsules represents the Company’s first product approved during DarmanTest to perform the BE study.

Lannett initially announced on June 02, 2008, that it would commence the marketing of Amantadine Hydrochloride Soft Gel Capsules 100 mg, within the next several months. According to the Company, annual sales for FY17 for both generic and brand product stood at $30 million. The Company initially received finished product from Banner Pharmacaps, Inc., under a supply agreement, for ANDA of Amantadine Hydrochloride Soft Gel Capsules USP 100 mg, the generic equivalent of USL’s Pharma’s Symmetrel®.

According to the Company, in the last 6 months, (as of June 2008), it received 5 ANDA approvals, including Phentermine Hydrochloride Capsules, Bethanechol Chloride Tablets (two separate ANDA approvals), Rifampin Capsules and Dipyridamole Tablets.

Other Approvals

On November 14, 2016, Lannett announced that it has received an approval from the FDA of its ANDA for Memantine Hydrochloride Tablets USP – 5 mg and 10 mg, which was a therapeutic equivalent to the reference listed drug, Namenda tablets – 5 mg and 10 mg. Net US sales for Memantine Hydrochloride Tablets USP – 5 mg, and 10 mg, at Average Wholesale Price (AWP) was about $50 million for FY15.

On May 16, 2017, the Company announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/mL), the therapeutic equivalent to the reference listed drug, Xyzal® Oral Solution, 2.5 mg/5 mL (0.5 mg/mL), of UCB Inc. Levocetirizine Dihydrochloride Oral Solution finds its application for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

Lannett holds a diverse spectrum of off-patent pharmaceutical products in a variety of dosage forms. The Company has also created a Specialty Pharma division to create the market for its first brand drug, C-Topical. According to the Company, its net sales were $151 million for FY13 and $193 million in the first 9 months for FY14.

Last Close Stock Review

At the close of trading session on Friday, June 16, 2017, Lannett’s stock price rose slightly by 0.27% to end the day at $18.50. A total volume of 690.18 thousand shares were exchanged during the session. At Friday’s closing price, the stock’s net capitalization stands at $686.91 million.

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