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Last updated on April 17, 2014 at 7:54 EDT

Latest Breckenridge Pharmaceutical Inc. Stories

2012-10-12 15:22:01

BOCA RATON, Fla., Oct. 12, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has entered into an agreement with Marksans Pharma, Ltd to market its Abbreviated New Drug Application (ANDA) for Gabapentin Capsules, the generic version of Neurontin® Tablets by Pfizer. The product was approved by the U.S. Food and Drug Administration (FDA) on July 21, 2011. Under the terms of this agreement, Marksans Pharma will manufacture and supply the product to Breckenridge...

2012-10-03 10:23:54

BOCA RATON, Fla., Oct. 3, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has entered into an agreement with Ajanta Pharma, Ltd. to market its Abbreviated New Drug Application (ANDA) for Risperidone Tablets, the generic version of Risperdal® Tablets by Janssen Pharma. The product was approved by the U.S. Food and Drug Administration (FDA) on August 24, 2011. Under the terms of this agreement, Ajanta Pharma will manufacture and supply the product to...

2012-06-27 14:22:17

BOCA RATON, Fla., June 27, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that Breckenridge and Alembic Pharmaceuticals Limited were named codefendants in a Paragraph IV lawsuit filed by Pfizer Inc. concerning their ANDA desvenlafaxine succinate extended-release tablets 50mg and 100mg, a generic version of Pristiq® by Pfizer Inc. Breckenridge and Alembic filed their Paragraph IV ANDA on the first-possible submission date and expects to share 180-day exclusivity...

2012-06-14 10:22:57

BOCA RATON, Fla., June 14, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that Breckenridge and Alembic Pharmaceuticals Limited have settled their Paragraph IV patent litigation with Novartis concerning Rivastigmine Tartrate Capsules, a generic version of Exelon® by Novartis, and that the U.S. Food and Drug Administration (FDA) approved their Abbreviated New Drug Application (ANDA). The companies will launch immediately. Alembic Pharmaceuticals Limited is the...

2012-05-04 10:25:32

BOCA RATON, Fla., May 4, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has finalized its agreement with Zhejiang Huahai Pharmaceuticals Co., Ltd. (Huahai) to market Nevirapine Tablets. Nevirapine 200mg Tablets are AB rated to Viramune® a non-nucleoside reverse transcriptase inhibitor (NNRTI) used to treat HIV-1 infection and AIDS, which is marketed by Boehringer Ingelheim. The current market is in excess of $100 million according to industry...

2012-01-06 14:09:00

BOCA RATON, Fla., Jan. 6, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc.announced that it has submitted Paragraph IV (PIV) certifications for seven (7) different Abbreviated New Drug Applications (ANDA) during the 2011 calendar year and intends to submit at least five (5) each year for the next several years. These submissions reflect Breckenridge's aggressive strategy to focus on Paragraph IV opportunities -- both blockbuster and niche products -- as an integral part of its business...

2011-12-09 14:22:00

BOCA RATON, Fla., Dec. 9, 2011 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration granted final approval for their Abbreviated New Drug Application (ANDA) for Methscopolamine Bromide Tablets. Methscopolamine Bromide Tablets are AB rated to Pamine®, a prescription medicine that is used as adjunctive therapy for the treatment of peptic ulcers. Pamine® is marketed by Kenwood Therapeutics. The current market...

2011-06-10 11:22:00

BOCA RATON, Fla., June 10, 2011 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Activella® 0.5mg/0.1mg Tablets. The company currently markets an equivalent to Activella® 1.0mg/0.5mg Tablets, as (Estradiol/Norethindrone Acetate 1.0mg/0.5mg) Tablets. Estradiol/Norethindrone...

2011-06-10 10:51:00

BOCA RATON, Fla., June 10, 2011 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Letrozole 2.5 mg Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA) for this product, which is being supplied under a licensing agreement. Letrozole Tablets are AB rated to Femara®, a $700 million dollar oncology drug marketed by Novartis. About Breckenridge: Breckenridge...

2011-05-16 10:43:00

BOCA RATON, Fla., May 16, 2011 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced that Breckenridge and Synthon Pharmaceuticals, Inc. have reached an agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving patent litigation related to Pioglitazone Hydrochloride 15 mg, 30 mg and 45 mg tablets, a generic equivalent version of Actos®. Under the terms of the agreement, Takeda granted Breckenridge and Synthon a...