Thursday, generic drug maker Lannett Company Inc. (LCI) said that it has received approval from the U.S. Food and Drug Administration or FDA for its abbreviated new drug applications for Hydromorphone Hydrochloride tablets.
The approved USP 2 mg,4 mg and 8 mg hydromorphone hydrochloride tablets is the generic equivalent of Purdue Pharmaceuticals' Dilaudid Tablets 2 mg, 4 mg and 8 mg.
Hydromorphone Hydrochloride tablets are indicated for the management of pain in patients where an opioid analgesic is appropriate.
Opioid analgesics, also known as narcotic analgesics, are pain relievers that act on the central nervous system. However, its use can sometimes lead to unwanted side effects, such as drowsiness, dizziness, breathing problems, and physical or mental dependence.
Arthur Bedrosian, president and chief executive officer said that other suppliers of Hydromorphone in the U.S. have ceased manufacturing the product and only one other supplier of Hydromorphone has all three dosage strengths.
The company noted that according to Wolters Kluwer, U.S. sales in 2008 of both generic and brand hydromorphone hydrochloride tablets was $170 million at average wholesale price.
Lannett expects to commence marketing of the drug within next few weeks and that the active ingredient used for the product will be produced at its Cody Laboratories.
LCI closed Thursday's regular trading at $6.75, up $0.27 or 4.17%, on the NYSE.
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