BALTIMORE, June 6 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cefdinir Powder for Oral Suspension, 125 mg/5 mL.
Lupin’s Cefdinir Suspension, 125 mg/5 mL is the AB-rated generic equivalent of Abbott Laboratories’ Omnicef(R) Suspension, 125 mg/5 mL which had U.S. sales of approximately $137 million for the 12-month period ending December 31, 2005, according to IMS Health. Total combined sales for Cefdinir capsules and suspensions were $634 million for the same time period.
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, “Today’s FDA approval of Cefdinir suspension and the recent approval of the capsule reinforces Lupin’s ability on submitting high-quality dossiers and gaining approvals on time. This approval further strengthens our position in the Cephalosporin market in the US.”
This is Lupin’s 12th ANDA approval by the US FDA to date and the second in its fiscal year. Lupin is the first company to receive ANDA approval for Cefdinir for both Capsule and Suspension forms.
About Lupin
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with strong research focus. It has a program for developing New Chemical Entities. The Company has a state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDs and Asthma.
For the financial year ended March 2006, the Company’s Revenues and Profit after Tax were Rs.16,610 million (US$ 375 million) and Rs.1,827 million (US$ 41 million) respectively. Please visit http://www.lupinworld.com for more information about Lupin Ltd.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top 6 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 http://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.
Contact: Edith St-Hilaire
Senior Marketing Manager 410-576-2000
Lupin Pharmaceuticals, Inc.
CONTACT: Edith St-Hilaire, Senior Marketing Manager, LupinPharmaceuticals, Inc., +1-410-576-2000
