Lannett Receives FDA clearance for Loxapine Capsules Print E-mail
By Staff and Wire Reports   
Tuesday, 27 September 2011 08:01
FDA calendarLannett Company, Inc. (AMEX: LCI) announced this morning that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) of Loxapine Capsules, 5 mg, 10 mg, 25 mg and 50 mg,  which are therapeutically equivalent to the reference listed drug, Loxitane® Capsules, 5 mg, 10 mg, 25 mg and 50 mg from Watson Pharmaceuticals.

Retail pharmacy sales of Loxapine Capsules at Average Wholesale Price (AWP) were approximately $22.3 million for the 12-month period ending June, 2011, according to Wolters Kluwer. Lannett expects to commence shipping the product in the next few weeks.

“We have now received five product approvals from the FDA over the last three months,” said Arthur P. Bedrosian, president and chief executive officer of Lannett. “Loxapine Capsules is an important addition to our product line-up.”
Loxapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Loxapine is in a group of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.

Lannett Company, Inc. is a generic pharmaceutical manufacturing company that develops, manufactures and distributes generic prescription pharmaceutical products in tablet, capsule and oral liquid forms to customers. It was founded in 1942.Lannett produces & distributes its own line of high quality pharmaceutical products. Its products are available to chain drug stores, wholesalers and distributors under Lannett's name or as a private label. Its capabilities include: Laboratory services like - Analytical, Development, Stability and Product identification; Product formulation and development; Granulation; Blending; Encapsulation; Compression; and Coating and Packaging - solid dosage forms.

There are currently 942,000 shares short in the stock, which are trading -43.71 % under their 52-week high of $7.00. The company has 28.34M shares outstanding with 51.66% held by insiders and 18.2% held by institutions. The float is said to be around 12.09M.



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