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Intrinsic Evidence Pointing to a Criticality of a Claimed Ratio Used to Construe the Term "About." (Fed. Cir. 2007, 06-1102) Caraco filed an ANDA with the intent to make and sell a pharmaceutical composition containing tramadol and acetaminophen with an average weight ratio of tramadol to acetaminophen of 1:8.67, and no less than a ratio of 1:7.5. In response, Ortho [...]

... size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the Food and Drug Administration. Digoxin is a drug product used ... a risk of lack of efficacy potentially resulting in cardiac instability. The recalled lots of Digoxin are listed below. Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with "437" Caraco Digoxin ...

... pill recall by posting this company press release on the agency's web site: "Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets ... company, states that: [A]ll tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, ... "double-dose" manufacturing problem. Those Digitek pills were distributed by Mylan Pharmaceuticals under the Bertek and UDL labels. The Digitek recall has resulted in personal ...

... . Harper Last Friday the Federal Circuit affirmed a district court ruling that Caraco Pharmaceutical Laboratories' ANDA for a generic version of Ortho-McNeil's Ultracet does not ... '691 patent, which recites (when read in conjunction with the two claims on which it depends): "A pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to ... -CV-5707-JCL-MF (D. N.J.), and Teva Pharmaceutical Industries, Ltd., No. 04-CV-886-HAA-GDH (D. N.J). ...

... ratio; the other claims distinctly point out ranges of weight ratios. For example, independent claim 1 reads: "A pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to acetaminophen is a weight ... . . . For these reasons, we conclude that the district court properly granted summary judgment of non-infringement in favor of defendant, Caraco Pharmaceutical Laboratories, Ltd., and against plaintiff, Ortho-McNeil Pharmaceutical, Inc.

Caraco Pharmaceutical Laboratories Ltd. is recalling all lots of Digoxin tablets because the defective product in Pennsylvania and throughout the nation might vary in size and deliver different doses of the drug. According ... drugs or supplements that are defective, they can and should be held responsible for the injuries they cause. As a manufacturer of pharmaceuticals, the company has an obligation to make a safe product, which includes various aspects such as thoroughly inspecting the product ...

"At the request of the FDA, U.S. Marshals raided generic drug manufacturer Caraco Pharmaceutical Laboratories, Ltd., shutting down manufacturing and seizing inventory. The action came after FDA inspections found that the drug maker was continuing to fail to meet federal safety and health requirements. In March 2009, Caraco recalled digoxin, a heart medication that requires exact dosage, after it was discovered that some tablets distributed were thicker or thinner than ...

... Suresh Pillai -- Settlement Announced in Ethyol® Infringement Suit Sun Pharmaceutical Industries, Ltd. and Medimmune LLC have announced a settlement of their patent dispute regarding ... filed suit in 2004, alleging that Sun and its U.S. affiliate, Caraco Pharmaceutical Laboratories Ltd., had infringed Medimmune's patents covering Ethyol®, U ... 591,731. The U.S. District Court for the District of Maryland, having noted that Medimmune stated that Sun and Caraco had not infringed any of the process claims ...

... et al. (in support of petitioner) __________________ Docket: 08-624 Title: Forest Laboratories, Inc., et al., v. Caraco Pharmaceutical Laboratories, Ltd. Issue: Whether a generic drug company has Article III standing to sue for a ... Foundation (in support of petitioner) Brief amicus curiae of Pfizer, Inc. (in support of petitioner) Brief amicus curiae of Ivax Pharmaceuticals, Inc. (in support of petitioner) __________________ Docket: 08-640 Title: Federal Insurance Company, et al., v. Kingdom of ...

Not even a year has passed since the massive recall of Digitek pills by Bertek/Mylan and Actavis, yet cardiac patients are facing yet another scare. On March 31, 2009, Caraco Pharmaceutical Laboratories, Ltd. announced a nationwide recall of all lots of its digoxin tablets due to potential manufacturing defects.The recall notice indicates that Caraco's digoxin pills may have been manufactured at a size larger than intended, with the result being that the ...