Latest Breckenridge Pharmaceutical Inc. Stories
BOCA RATON, Fla., March 26, 2013 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has entered into an agreement with Aptalis Pharmatech, Inc. to market Propranolol Hydrochloride Extended-Release Capsules, USP the generic version of Inderal® LA by Akrimax Pharmaceuticals, LLC, under Aptalis Pharmatech, Inc.'s Abbreviated New Drug Application (ANDA). The product was approved by the U.S. Food and Drug Administration (FDA) on July 15, 2011. Under the terms of...
BOCA RATON, Fla., Feb. 13, 2013 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Pioglitazone Hydrochloride Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by Synthon Pharmaceuticals, Inc., and will be available in 15 mg, 30 mg, and 45 mg strengths. Breckenridge is launching its ANDA prior to patent expiration pursuant to a...
BOCA RATON, Fla., Dec. 30, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Rizatriptan Benzoate Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA) for this product, which is being manufactured and supplied by Natco Pharma Limited, and will be available in both 5mg and 10mg strengths. Rizatriptan Benzoate Tablets are AB rated to Maxalt®, a $320 million dollar brand drug...
BOCA RATON, Fla., Dec. 18, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Prescription Lansoprazole Delayed-Release Capsules. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by Natco Pharma Limited, and will be available in both 15mg and 30mg strengths. Lansoprazole Delayed-Release Rx Capsules are AB rated to Prevacid®, a Proton Pump...
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...
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...
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...
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...
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 data....
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...
