Ranbaxy got approval of Cefuroxime Axetil for Oral Suspension
Ranbaxy Lab announced today that RLL has received approval from the USFDA to manufacture and market Cefuroxime Axetil for Oral Suspension USP, 125 mg/5mL and 250 mg/5mL. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Ceftin(R) by GlaxoSmithKline. Total annual market sales for Cefuroxime Axetil Suspension were $28.7 million.
Cefuroxime Axetil Suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the following conditions: Pharyngitis/Tonsillitis, Acute Bacterial Otitis Media and Impetigo. Ranbaxy is pleased to receive this approval for Cefuroxime Axetil Suspension that now allows us to offer both dosage forms for a product that is highly prescribed. We will offer Cefuroxime Axetil Suspension as a pleasant tasting liquid intended primarily for children that will ease in the acceptance and administration of this anti-infective. This product will further expand our product portfolio of affordable generic alternatives and will be launched immediately to all classes of trade," said Jim Meehan, Vice President of Sales and Distribution for RPI.
Ranbaxy Lab announced today that RLL has received approval from the USFDA to manufacture and market Cefuroxime Axetil for Oral Suspension USP, 125 mg/5mL and 250 mg/5mL. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Ceftin(R) by GlaxoSmithKline. Total annual market sales for Cefuroxime Axetil Suspension were $28.7 million.
Cefuroxime Axetil Suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the following conditions: Pharyngitis/Tonsillitis, Acute Bacterial Otitis Media and Impetigo. Ranbaxy is pleased to receive this approval for Cefuroxime Axetil Suspension that now allows us to offer both dosage forms for a product that is highly prescribed. We will offer Cefuroxime Axetil Suspension as a pleasant tasting liquid intended primarily for children that will ease in the acceptance and administration of this anti-infective. This product will further expand our product portfolio of affordable generic alternatives and will be launched immediately to all classes of trade," said Jim Meehan, Vice President of Sales and Distribution for RPI.
Daptomycin orange book listing
Cubist Pharma announced that the USFDA has received today the re-listing application for its U.S. Patent RE39071. Patents are considered listed in the Orange Book upon receipt by FDA, and this is one of three patents for daptomycin listed in the Orange Book. We expect that the FDA will publish the re-listed patent information in its next regular Orange Book update.US RE39071 covers the pharmaceutical composition of CUBICIN(R) (daptomycin for injection) and expires in June 2016. On September 11, 2007 Cubist had asked the FDA to de-list the pharmaceutical composition patent from the Orange Book so that it could seek a technical correction. The U.S. Patent and Trademark Office on January 29, 2008 granted a Certificate of Correction for the pharmaceutical composition patent.
Cubist Pharma announced that the USFDA has received today the re-listing application for its U.S. Patent RE39071. Patents are considered listed in the Orange Book upon receipt by FDA, and this is one of three patents for daptomycin listed in the Orange Book. We expect that the FDA will publish the re-listed patent information in its next regular Orange Book update.US RE39071 covers the pharmaceutical composition of CUBICIN(R) (daptomycin for injection) and expires in June 2016. On September 11, 2007 Cubist had asked the FDA to de-list the pharmaceutical composition patent from the Orange Book so that it could seek a technical correction. The U.S. Patent and Trademark Office on January 29, 2008 granted a Certificate of Correction for the pharmaceutical composition patent.
Invitrogen, Agilent Technologies Settle Multiple Patent Litigations
Invitrogen Corporation and Agilent Technologies (Source: BUSINESS WIRE) have jointly announced a confidential settlement of multiple patent litigations pending between the two companies. The settlement resolves three patent infringement lawsuits between Invitrogen and Stratagene, Inc. Agilent acquired Stratagene in 2007.
These patent litigations between the companies had been pending since 2000 and 2001. In June 2000, Invitrogen sued Stratagene in the United States District Court for the District of Maryland, Southern Division, for infringement of Invitrogen's U.S. Patent Nos. 6,063,608, 5,244,797, and 5,405,776 relating to the use and sale of RNase H minus reverse transcriptase (RT) products. This case had been stayed pending resolution of a related litigation with Clontech.
On March 12, 2001, Invitrogen filed suit against Stratagene for infringement of U.S. Patent No. 4,981,797. That patent covers a process for producing E. coli cells that are more effective at absorbing foreign DNA and thereby more "competent." In 2006, the United States District Court for the Western District of Texas, Austin Division, entered judgment awarding Invitrogen $16.2 million plus prejudgment interest, post-judgment interest, attorneys' fees and costs, and entered an injunction against further infringement. Stratagene appealed the judgment to the United States Court of Appeals for the Federal Circuit.
In November 2001, Stratagene filed suit against Invitrogen in the United States District Court for the District of Maryland, Southern Division, for infringement of U.S. Patent No. 5,556,772 related to the use and sale of certain DNA polymerase blend products. The case had been stayed by the Court pending a reissuance proceeding before the United States Patent Office.
Under the terms of the agreement, Agilent will make an undisclosed settlement payment to Invitrogen. In addition, Agilent will discontinue sales of its RNase H minus RT products and Invitrogen will obtain a license from Agilent and pay an undisclosed royalty to sell its DNA polymerase blend products. All litigation will be dismissed. No other details of the settlement were disclosed.
Invitrogen Corporation and Agilent Technologies (Source: BUSINESS WIRE) have jointly announced a confidential settlement of multiple patent litigations pending between the two companies. The settlement resolves three patent infringement lawsuits between Invitrogen and Stratagene, Inc. Agilent acquired Stratagene in 2007.
These patent litigations between the companies had been pending since 2000 and 2001. In June 2000, Invitrogen sued Stratagene in the United States District Court for the District of Maryland, Southern Division, for infringement of Invitrogen's U.S. Patent Nos. 6,063,608, 5,244,797, and 5,405,776 relating to the use and sale of RNase H minus reverse transcriptase (RT) products. This case had been stayed pending resolution of a related litigation with Clontech.
On March 12, 2001, Invitrogen filed suit against Stratagene for infringement of U.S. Patent No. 4,981,797. That patent covers a process for producing E. coli cells that are more effective at absorbing foreign DNA and thereby more "competent." In 2006, the United States District Court for the Western District of Texas, Austin Division, entered judgment awarding Invitrogen $16.2 million plus prejudgment interest, post-judgment interest, attorneys' fees and costs, and entered an injunction against further infringement. Stratagene appealed the judgment to the United States Court of Appeals for the Federal Circuit.
In November 2001, Stratagene filed suit against Invitrogen in the United States District Court for the District of Maryland, Southern Division, for infringement of U.S. Patent No. 5,556,772 related to the use and sale of certain DNA polymerase blend products. The case had been stayed by the Court pending a reissuance proceeding before the United States Patent Office.
Under the terms of the agreement, Agilent will make an undisclosed settlement payment to Invitrogen. In addition, Agilent will discontinue sales of its RNase H minus RT products and Invitrogen will obtain a license from Agilent and pay an undisclosed royalty to sell its DNA polymerase blend products. All litigation will be dismissed. No other details of the settlement were disclosed.
Meditrina Signs Exclusive Global Licensing Agreement with AstraZeneca
Meditrina Pharmaceuticals, Inc., today announced that it is has completed a global licensing agreement to make, develop and commercialize products under AstraZeneca’s IP and know-how regarding the use of aromatase inhibitors (AI) in combination with estrogen and progestin to treat endometriosis. This agreement expands Meditrina’s clinical stage product portfolio which currently includes Femathina (MPI-674), an AI that Meditrina is repurposing for the treatment of several serious women’s health conditions including endometrial thinning prior to endometrial ablations in premenopausal women with abnormal uterine bleeding (AUB). Femathina recently completed a phase II clinical trial.
Meditrina Pharmaceuticals, Inc., today announced that it is has completed a global licensing agreement to make, develop and commercialize products under AstraZeneca’s IP and know-how regarding the use of aromatase inhibitors (AI) in combination with estrogen and progestin to treat endometriosis. This agreement expands Meditrina’s clinical stage product portfolio which currently includes Femathina (MPI-674), an AI that Meditrina is repurposing for the treatment of several serious women’s health conditions including endometrial thinning prior to endometrial ablations in premenopausal women with abnormal uterine bleeding (AUB). Femathina recently completed a phase II clinical trial.
USFDA to take more time for reviewing Ropinirole Extended Release Tablets
SkyePharma PLC has been informed that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for GlaxoSmithKline's (NYSE: GSK) Requip(R) XLTM Extended Release tablets. The PDUFA action date is the date by which the FDA is expected to issue a response on a pending new drug application. Following the approvable letter for Requip XL issued in December 2007, GlaxoSmithKline submitted a response to the FDA. A final decision from the FDA had been expected in Q1 2008. However, GSK has recently submitted additional information on food effect to the FDA. The Agency has determined that they would not have sufficient time to review this information prior to the Q1 action date and the final decision is now expected to be received in Q2 2008. Requip(R) XLTM is the first and only once-daily oral non-ergot dopamine agonist indicated to treat the signs and symptoms of idiopathic Parkinson's disease. It uses SkyePharma's patented GEOMATRIXTM technology and has been designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. The product is expected to be available in pharmacies shortly after the anticipated approval. SkyePharma PLC is pleased to note the launch in France last week of Requip(R) LP Extended Release tablets (as Requip(R) XLTM Extended Release tablets are known in France).
SkyePharma PLC has been informed that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for GlaxoSmithKline's (NYSE: GSK) Requip(R) XLTM Extended Release tablets. The PDUFA action date is the date by which the FDA is expected to issue a response on a pending new drug application. Following the approvable letter for Requip XL issued in December 2007, GlaxoSmithKline submitted a response to the FDA. A final decision from the FDA had been expected in Q1 2008. However, GSK has recently submitted additional information on food effect to the FDA. The Agency has determined that they would not have sufficient time to review this information prior to the Q1 action date and the final decision is now expected to be received in Q2 2008. Requip(R) XLTM is the first and only once-daily oral non-ergot dopamine agonist indicated to treat the signs and symptoms of idiopathic Parkinson's disease. It uses SkyePharma's patented GEOMATRIXTM technology and has been designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. The product is expected to be available in pharmacies shortly after the anticipated approval. SkyePharma PLC is pleased to note the launch in France last week of Requip(R) LP Extended Release tablets (as Requip(R) XLTM Extended Release tablets are known in France).
European Commision approves Roche drug
Roche said the European Commission has approved its oral chemotherapy Xeloda (capecitabine) for the treatment of metastatic colorectal cancer in combination with any chemotherapy in all lines of treatment with or without Avastin. The new approval means that more patients suffering from colorectal cancer that has spread will now be able to take advantage of effective and innovative treatments with proven patient benefits. Approval was based on the pivotal studies demonstrating Xeloda tablets providing patients with a more flexible treatment option with less hospital treatment time, whilst continuing to deliver the same survival benefits and safety as the previous standard chemotherapy intravenous (iv) 5-FU. The study also proved that Avastin in combination with chemotherapy allows patients to live significantly longer without their cancer progressing.
Roche said the European Commission has approved its oral chemotherapy Xeloda (capecitabine) for the treatment of metastatic colorectal cancer in combination with any chemotherapy in all lines of treatment with or without Avastin. The new approval means that more patients suffering from colorectal cancer that has spread will now be able to take advantage of effective and innovative treatments with proven patient benefits. Approval was based on the pivotal studies demonstrating Xeloda tablets providing patients with a more flexible treatment option with less hospital treatment time, whilst continuing to deliver the same survival benefits and safety as the previous standard chemotherapy intravenous (iv) 5-FU. The study also proved that Avastin in combination with chemotherapy allows patients to live significantly longer without their cancer progressing.
Tramadol OD in Canada
Paladin and Nycomed announced that the companies have entered into a Canadian Co-Promotion Agreement for Tridural once-daily tramadol. Paladin acquired the Canadian license to Tridural from Labopharm Inc. in July 2007 and launched Tridural in September 2007. Under this Co-Promotion Agreement, Nycomed Canada will share brand responsibilities and expenses with Paladin and will deploy a national primary care sales force to promote Tridural. Paladin will continue to handle distribution of Tridural and will also continue to promote Tridural using its primary care sales force. Tridural is a unique treatment option developed as a first-line therapy that provides 24-hour pain relief from a single tablet taken once-daily for adult patients with persistent pain who require treatment for several days or more. Tridural is based on Labopharm's proprietary controlled-release technology, Contramid, and a novel dual matrix delivery system that facilitates both rapid and sustained drug release, maintaining optimal therapeutic blood levels of tramadol for a full 24-hour period. Tridural offers physicians and patients greater treatment flexibility based on its relatively rapid two-day titration schedule, which could help patients reach their optimum daily dose faster than any other approved once-daily tramadol product and quickly achieve effective pain relief. In addition, Tridural has a demonstrated safety profile based on clinical trial experience of more than 2,400 patients globally and almost two years of commercial experience. As a tramadol product, Tridural provides pain relief through its action at three sites related to analgesic activity: the mu-opioid receptor, the serotonin receptor, and the norepinephrine receptor. "Our agreement with Nycomed to share brand expenses and to deploy an additional primary care sales force to promote Tridural will allow us to increase the potential for this important product," said Jonathan Goodman, president and CEO of Paladin. "We are excited to find a likeminded partner who shares our commitment to improving the treatment of pain in Canada to the benefit of patients". "Tridural presents a compelling product opportunity in a large, underserved market. We believe that Nycomed's additional marketing and sales resources will more rapidly drive the adoption of Tridural as the cornerstone of treatment for patients with persistent, moderate pain. We are very pleased to be working in partnership with Paladin,." said John Suk, president and CEO of Nycomed Canada.
