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ANDA in Medical News

Caraco Pharmaceutical Laboratories, Ltd. Announces Settlement of Ethyol(R) ANDA Patent Litigation

DETROIT, Aug. 3 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD ) announces today that it has executed a settlement agreement with MedImmune, stipulating the dismissal of the lawsuits filed in the United States District Court for the District of Maryland r...

FDA Accepts Tris Pharma's ANDA with Paragraph IV Certification for a Generic Equivalent to Delsym

SOUTH BRUNSWICK, N.J., July 16 /PRNewswire/ -- Tris Pharma, Inc., a drug delivery and specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 12-hour sust...

Caraco Pharmaceutical Laboratories, Ltd. Enters Into Asset Purchase Agreement with Forest Laboratories, Inc. to Settle Lexapro(R) (escitalopram oxalate) ANDA Patent Litigation

DETROIT, July 10 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD ) announced that, as part of the settlement of the legal proceedings related to Lexapro(R) (escitalopram oxalate) tablets, it entered into an Asset Purchase Agreement with Forest Laboratories, Inc...

Handa Pharmaceuticals Announces Submission of its First-to-File ANDA for AstraZeneca's SEROQUEL(R) XR

FREMONT, Calif., July 31 /PRNewswire/ -- Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Quetiapine Fumarate Extended-Release Tablets, the generic version of AstraZenec...

Spear Pharmaceutical Inc.'s ANDA for Fluorouracil Cream 5%

NEW YORK, May 20 /PRNewswire/ -- Spear Pharmaceuticals, Inc. received FDA approval for, and began shipping, Fluorouracil Cream 5%, USP, a generic equivalent to Valeant's Efudex(R) Cream. On April 11, 2008, the FDA approved the ANDA (Abbreviated New Drug Application) based on Spear's 318 patien...

Breckenridge Pharmaceutical Enters Agreement With Helm AG (Hamburg, Germany) to Develop Additional ANDA Project

BOCA RATON, Fla., April 1, 2008 /PRNewswire/ -- Breckenridge announced today that it has entered into another separate agreement with Helm AG to develop and manufacture a generic ANDA product. Under terms of this new agreement, Breckenridge will submit an ANDA to the U.S. Food and Drug Adminis...

Breckenridge Pharmaceutical Settles 'Paragraph IV' Litigation and Receives FDA Approval for its Oxcarbazepine ANDA

BOCA RATON, Fla., Jan. 11 /PRNewswire-FirstCall/ -- Breckenridge Pharmaceutical, Inc. announced today that it settled "Paragraph IV" litigation with Novartis concerning Trileptal(R) and that the U.S. Food and Drug Administration approved Breckenridge's Abbreviated New Drug Application for oxca...

Nothing But Nets, Gavin DeGraw and Tom Cavanagh Help Save Lives in Uganda

Singer and 'Trust Me' actor partner with Nothing But Nets to deliver bed nets to refugee camp in Uganda Washington, DC (PRWEB) March 11, 2009 -- The United Nations Foundation's Nothing But Nets campaign, a global, grassroots initiative to prevent malaria, is teaming u...

Mylan Announces Tentative FDA Approval for Its ANDA

Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Hydrochloride Extended-release Tablets, 12.5 mg and 25 mg. Mylan's ANDA is ...

Perrigo Announces FDA Approval for Generic Version of NASACORT(R) AQ

...fication. Perrigo's partner Teva was the first applicant to file a complete anda with a Paragraph IV certification for NASACORT AQ. The product was develope...terms of a previously disclosed settlement, Teva will be able to market the anda product which is manufactured by Perrigo under license from Sanofi-Aventis ...

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ANDA in Biological Technology

U.S. District Court Decision About Eisai's Legal Action Over Aricept ODT(R) ANDA Filing

TOKYO and WOODCLIFF LAKE, N.J., Dec. 27 /PRNewswire/ --- Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu) (collectively "Eisai") filed a lawsuit in August 2006 against Mutual Pharmaceutical Co., In...

New Report Just Published: World Prostate Cancer Therapeutics Market Report

...gnet Enters into Agreement with AsymmetRx to Distribute 'Prostate-63' Tests II-79 Mylan Pharmaceuticals Obtains FDA Approval for Finasteride's anda II-79 Aeterna Zentaris Enters into Agreement with Nippon Kayaku II-79 Progenics Pharmaceuticals Broadens Association with Seattle Genetics...

Shire Files Lawsuit Against Natco Pharma for Infringement of FOSRENOL(R) (lanthanum carbonate) Patents

.... 7,381,428 ("'428 Patent"); The lawsuit was filed in response to an anda (Abbreviated New Drug Application) filed by Natco seeking FDA approval to m...ragraph IV notification letter, the FDA must refrain from approving Natco's anda for 30 months, or until a district court decision finding that the patents ...

Mylan Confirms Four First-to-File Challenges

...istrict Court of New Jersey in connection with the anda filing for Eszopiclone Tablets, 1 mg, 2 mg and 3 m... District Court in Delaware in connection with the anda filing for Erlotinib Hydrochloride (HCl) Tablets, ...uthern District of New York in connection with the anda filing for Lanthanum Carbonate Chewable Tablets, 5...

Shire Files Lawsuit Against Mylan for Infringement of FOSRENOL(R) (Lanthanum Carbonate) Patent

...iled its patent infringement lawsuit within 45 days of receiving Mylan's Paragraph IV notification letter, the FDA must refrain from approving Mylan's anda for 30 months, or until a District Court decision finding that the patent is invalid or not infringed, whichever occurs earlier. The stay on generic a...

RoundTable Healthcare Partners Facilitates Product Acquisition for CorePharma

...d exclusively on the healthcare industry, announced today that its portfolio company CorePharma LLC ("CorePharma") has completed the acquisition of an anda for Leucovorin Calcium tablets. Leucovorin Calcium tablets are the generic equivalent to the Wellcovorin(R) brand previously marketed by Burroughs Wel...

Shire Files Lawsuit Against Barr Laboratories for Infringement of FOSRENOL(R) (Lanthanum Carbonate) Patents

...tent No. 7,465,465 ("'465"). The lawsuit was filed in response to an anda (Abbreviated New Drug Applications) filed by Barr seeking FDA approval to m...aragraph IV notification letter, the FDA must refrain from approving Barr's anda for 30 months, or until a district court decision finding that the patents ...

SCOLR Pharma, Inc. Reports Fourth Quarter 2008 Financial Results

...ity of effect for the duration of the study, and had no significant adverse events; Received a Complete Response Letter from the FDA for our anda for a 120 milligram 12-hour pseudoephedrine tablet based on our patented CDT platform; Advanced work with Dr. Reddy's Laboratories on a confi...

KV Pharmaceutical Enters Into Consent Decree With FDA

... agreed that it will not distribute certain products, including its prenatal vitamins and hematinic products, until the products are approved by FDA's anda or NDA processes. "We have been working diligently with the FDA for the last two months to reach agreement on a clear path forward to permit KV ...

Frontage Laboratories Continues to Grow Its China Business and Add Corporate Financial, Regulatory and Clinical Pharmacology Talent

...eter R&D center and continued access to Beijing Pharma's GMP manufacturing areas. Frontage will also collaborate with Beijing Pharma to develop 12 anda products over the next 3-5 years, which will be marketed in China, Europe and the U.S. Frontage has been operating in China for 3 years, and serves b...

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