Par Pharmaceutical Begins Shipment of Generic Risperdal M-TAB
WOODCLIFF LAKE, N.J., June 2 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it began shipping 0.25 mg, 3 mg and 4 mg strengths of risperidone ODT to the trade. Risperidone ODT is a generic version of Janssen Pharma's Risperdal(R) M-TAB. Annual U.S. sales of Risperdal M-TAB were approximately $89 million in 2008, according to IMS Health data. Par has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for these three strengths of the product.
Important information about risperidone ODT
Risperidone is an atypical antipsychotic agent indicated for the acute and maintenance treatment of schizophrenia in adults and alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults. Due to Janssen Pharmaceuticals Corporation's marketing exclusivity rights, this drug is not labeled for use in pediatric patients with schizophrenia, bipolar mania, or autistic disorder.
There is a black box warning associated with this product due to increased mortality in elderly patients with dementia-related psychosis. Refer to full prescribing information for complete boxed warning.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.
Safe Harbor Statement
Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.