Lupin Pharmaceuticals, Inc. Receives US FDA Approval for Ziprasidone HCl Capsules
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- Published on Thursday, 24 May 2007 04:00
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BALTIMORE, MD, USA | May 22, 2007 | Lupin Pharmaceuticals, Inc. announced today that on May 16, 2007 it received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Ziprasidone Hydrochloride Capsules 20mg, 40mg, 60mg and 80mg. Ziprasidone, an antipsychotic drug, is indicated for the treatment of schizophrenia and bipolar disorder. Given that the company filed the ANDA on the earliest possible NCE date, this ensures that there will be limited competition when the product goes generic.
Lupin's Ziprasidone HCl Capsules are the AB-rated generic equivalent of Pfizer's Geodon(R) Capsules. Annual product sales in the U.S. of the capsules were approximately $760 million for the twelve months ended December 2006, based on IMS data.
Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. commented, "We are pleased to receive this tentative approval for Ziprasidone Hydrochloride Tablets. This product represents our second approval in the CNS segment and will be launched following final approval from the FDA."
With this approval, Lupin now has 22 ANDAs approved by the US FDA.
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with strong research focus. It has a program for developing New Chemical Entities. The Company has state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDS and Asthma.
For the financial year ended March 2007, Lupin's Revenues and Profit after Tax were Rs.20, 289 million (US$ 475 million) and Rs. 3,021 million (US$ 70 million) respectively.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top five Pharmaceutical companies in India. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit www.lupinpharmaceuticals.com.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management's expectations and intentions as of this date.
Lupin expressly disavows any obligation to update the information presented in this release
SOURCE: Lupin Pharmaceuticals, Inc.