Category: Oral Medication

Lilly - Boehringer - logo

Type 2 Diabetes Drug, Linagliptin, Receives Positive Opinion From EMA and CHMP

The European Medicines Agency's (EMA) medicinal committee issued an opinion recommending the approval of linagliptin, 5 mg, film-coated tablets (to be marketed under the trade name Trajenta in Europe) for the treatment of adults with type 2 diabetes. If adopted by the European Commission, the drug made and distributed by Eli Lilly and Boehringer Ingelheim, will be the only...
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Long Term Use of Diabetes Drug Actos May Increase Risk of Cancer

The U.S. Food and Drug Administration (FDA) issued a safety announcement informing the public that use of the type 2 diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines...
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Lilly - Boehringer - logo

New Type 2 Diabetes Treatment Tradjenta Now Available in U.S. Pharmacies

The new type 2 diabetes drug Tradjenta (linagliptin) is now available by prescription in pharmacies across the United States including Walgreens, CVS, Rite Aid following the U.S. Food and Drug Administration (FDA) approval of the drug on May 2, 2011. Tradjenta was approved as a prescription medication to be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes...
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Lilly - Boehringer - logo

FDA Approves Tradjenta for Treatment of Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim and Eli Lilly's type 2 diabetes drug Tradjenta (linagliptin) as a medication used along with diet and exercise to lower blood sugar in adult patients. The drug can be used as monotherapy or in combination with other commonly prescribed medications...
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Bristol-Myers Logo

Type 2 Diabetes Drug, ONGLYZA, Approved for Treatment of Renal Impairment by EU

The European Commission approved a label update for ONGLYZA® (saxagliptin) in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment following results of a new study submitted by AstraZeneca and Bristol-Myers Squibb Company. The approved dosage for the patient group is a new once-daily 2.5 mg dose...
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Novo Nordisk

Novo Nordisk Intends to Appeal Adverse Ruling in Prandin (repaglinide) Patent Case

Novo Nordisk announced it would appeal the US District Court for the Eastern District of Michigan's ruling regarding Novo Nordisk's US patent covering combination drugs Prandin and PrandiMet. The district court ruled that the patent, which covers the combination use of repaglinide and metformin for the treatment of type 2 diabetes, is invalid and unenforceable...
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Mylan logo

Generic Version of Bayer’s Type 2 Diabetes Drug Precose Approved by FDA

The FDA has given final approval to Mylan Pharmaceuticals Abbreviated New Drug Application (ANDA) for Acarbose Tablets, 25 mg, 50 mg and 100 mg. Acarbose is the generic version of Bayer's Precose tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes...
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Bristol-Myers Logo

New Type 2 Diabetes Drug Kombiglyze XR Now Available Across the US

Bristol-Myers Squibb Company and AstraZeneca announced that type 2 diabetes drug Kombiglyze XR (saxagliptin and metformin HCl extended-release), approved by the FDA on November 5, 2010, is now available by prescription in pharmacies across the United States. Kombiglyze XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic...
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TEVA

Teva To Market a Generic Version of ACTOS in 2012

Takeda Pharmaceutical Company Limited has granted Teva Pharmaceutical Industries Ltd. a license to market a generic version of ACTOS® in the U.S. beginning on August 17, 2012, and a generic version of ACTOplus met® beginning December 14, 2012. The license was granted following an agreement to settle patent litigation related to Teva's generic versions of Takeda's ACTOS® (pioglitazone HCl) and ACTOplus met® (pioglitazone HCl and metformin HCl) in the United States...
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