Pharma news (drug approvals/filings/litigation)

Perrigo got Final Approval on Clobetasol Propionate Foam
Perrigo announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Foam, 0.05%.
The product is a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand, Olux(R) Foam, 0.05%, were approximately $85 million according to Wolters Kluwer data for the 12 months ending January 2008. As the first filer, Perrigo will be eligible for 180 days of generic marketing exclusivity once it launches the product.
In late 2005, Connetics Corporation, which sells the brand drug, filed a patent infringement suit against Perrigo in the United States District Court for the District of New Jersey following Perrigo's paragraph IV patent certification in its ANDA stating that the Connetics' patent is invalid, unenforceable, or will not be infringed by Perrigo's ANDA. In response to a motion filed by Connetics last Thursday, the Court temporarily restrained Perrigo, as of March 7, 2008, from manufacturing, using, offering to sell, selling or importing into the United States its product pending the outcome of a hearing on March 19, 2008. On that date, the Court will hear arguments on Perrigo's pending Summary Judgment Motion as well as Connetics' Motion for a Preliminary Injunction.
Akorn-Strides Got approval for Tobramycin injection
Akorn-Strides today announced the approval of an ANDA for Tobramycin Injection USP, 80 mg/2mL and 1.2 grams/30mL. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn and Strides Arcolab Limited. The primary mission for the Joint Venture is developing liquid, lyophilized and dry powder fill generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines. Tobramycin Injection is an antibiotic and is indicated for the use in treating or preventing infections that are proven or strongly suspected to be caused by susceptible bacteria. Recent IMS data estimates an annual marketsize of approximately $19 million.
Sigma-Aldrich settle patent dispute on Lentivector technology
Sigma-Aldrich , Oxford BioMedica and Open Biosystems have jointly announced a confidential settlement of their patent litigation. Sigma-Aldrich and Oxford BioMedica agreed to dismiss the lawsuit brought against Open Biosystems. Open Biosystems agreed to dismiss its counterclaims in the lawsuit. As part of the settlement Open Biosystems will acquire certain license rights under the Oxford BioMedica patents for use of the LentiVector technology in research activities.
Spectrum got approval of Levoleucovorin
Spectrum Pharma announced that it has received marketing approval from the USFDA for Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. Levoleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin). The Company currently expects its commercial launch by June 2008.Levoleucovorin was reviewed under a full NDA, and included an Oncologic Drug Advisory Committee (ODAC) review. Spectrum anticipates that the drug will be listed without any therapeutically equivalent product in the FDA Orange Book. Drugs without therapeutic equivalents are considered 'single source drugs' which under section 1847A of the Social Security Act generally qualify for a separate reimbursement code with CMS.
Schering-Plough files new drug application with FDA for over-the-counter Zegerid (Omeprazole/sodium bicarbonate)
Schering-Plough announced that it has submitted a NDA to the USFDA for Zegerid (Omeprazole/Sodium bicarbonate) , the company's branded over-the-counter product to treat frequent heartburn.The NDA was submitted under the terms of a license agreement with Santarus Inc. for the exclusive U.S./Canadian rights to market Zegerid proton pump inhibitor products using Santarus' patented technology.
In June 2004 the FDA approved an immediate release preparation of omeprazole/sodium bicarbonate that does not require an enteric coating. This preparation employs sodium bicarbonate as a buffer to protect omeprazole from gastric acid degradation. This allows for the production of chewable tablets. This combination preparation is marketed in the United States by Santarus under the trade name Zegerid. Zegerid is marketed as capsules, chewable tablets, and powder for oral suspension. Zegerid is most useful for those patients who suffer from nocturnal acid breakthrough or those patients who desire immediate relief.
Dabur got approval for Irinotecan hydrochloride injection in Italy and Denmark
Dabur Pharma Ltd has received approvals for Irinotecan hydrochloride injection, generic version of Pfizer's Camptosar, in Italy and Denmark. The company had successfully launched the generic version of the drug in the US recently. It has also received approval for the drug in the UK. Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. It is also indicated for patients with metastatic carcinoma of the colon or rectum where disease has recurred or progressed following initial fluorouracil based therapy.