PITTSBURGH, Jan. 19, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its Mylan Institutional business has launched Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL and 1500 mg/100 mL, for intravenous use. Mylan's launch of this new product, which has been approved by the U.S. Food and Drug Administration (FDA), marks the first time that multiple strengths (500 mg, 1000 mg and 1500 mg) of premixed Levetiracetam will be supplied in ready-to-administer bags of Sodium Chloride Injection (100 mL). This product is an antiepileptic drug indicated for certain types of seizures.(1)
Mylan CEO Heather Bresch said: "The launch of this product is another example of Mylan's commitment to deliver new and innovative products to our institutional customers. We are excited to be the first and only company to offer three strengths of Levetiracetam in ready-to-administer bags, which assist in the ease, accuracy and convenience of dosing. The launch reflects our commitment to innovate to meet unmet needs and our strategy of expanding Mylan's product portfolio across the generic, specialty and niche market segments."
Mylan Institutional president, Matt Erick, added: "The addition of Levetiracetam in Sodium Chloride Injection to our basket of differentiated pharmaceutical products supports our business strategy to partner with customers and increase their efficiency by offering quality and convenience in one unique packaging presentation."
Previously, the only available version of Levetiracetam for Injection came in a vial presentation, 500 mg/5 mL. This product had U.S. sales of approximately $66.3 million for the 12 months ending Sept. 30, 2011, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
This press release includes statement that may constitute "forward-looking statements" (including with regard to product launches and the company's strategies) as well as other information that is necessarily subject to risks, uncertainties and assumptions. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, market acceptance of the company's products, the impact of competition and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
(1) Levetiracetam in Sodium Chloride Injection for Intravenous Use is an antiepileptic drug indicated for adults (16 years and older) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures; Myoclonic seizures in patients with juvenile myoclonic epilepsy; Primary generalized tonic-clonic seizures. Safety Information includes: Neuropsychiatric adverse reactions, including: 1) somnolence and fatigue (including asthenia, dizziness), 2) coordination difficulties, and 3) behavioral abnormalities (e.g., psychotic symptoms, suicide ideation, and less than or equal to 5% depression, nervousness, anxiety, emotional lability and other abnormalities); infection. Patients should be monitored for neuropsychiatric signs and symptoms. Withdrawal Seizures: Levetiracetam should be gradually withdrawn. Hematological abnormalities have been noted.
Please see full prescribing information available at www.premixedleve.com for warnings, precautions, adverse reactions and other risk information.
SOURCE Mylan Inc.