New Drug Application News and Research

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FDA waives NDA filing fee for Antares' Anturol NDA

Antares Pharma, Inc. today announced the receipt from the U.S. Food and Drug Administration (FDA) of a waiver, on February 8, 2011, for the $1,500,000 New Drug Application (NDA) filing fee for Anturol® Gel for overactive bladder (OAB).

14 Feb 2011

Neoprobe achieves accrual goal in Lymphoseek Phase 3 study in breast cancer/melanoma

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that a multi-center Phase 3 study of Lymphoseek® has enrolled clinical subjects to achieve the minimum analysis goal of 196 lymph nodes, the study's primary accrual objective.

14 Feb 2011

Tarsa completes oral calcitonin Phase III trial for treatment of postmenopausal osteoporosis

Tarsa Therapeutics, Inc. today announced completion of its global Phase III ORACAL trial testing the company's once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis. Results from the ORACAL trial are expected in early spring. In addition, Tarsa announced initiation of a new Phase II study of its oral calcitonin for the prevention of postmenopausal osteoporosis.

14 Feb 2011

Positive results from Glenmark's crofelemer Phase 2 study in acute watery diarrhea

Napo Pharmaceuticals, Inc. is pleased to announce the positive results of a successfully completed Phase 2 study of crofelemer for the treatment of hospitalized adult patients with mild to moderate acute watery diarrhea conducted by its partner Glenmark Pharmaceuticals Ltd..

14 Feb 2011

FDA accepts King's ACUROX NDA for filing with Priority review classification

Acura Pharmaceuticals, Inc. today announced that it has been informed by King Pharmaceuticals Research and Development Inc. (King) that King's New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets was accepted for filing by the US Food and Drug Administration (FDA) with a Priority review classification and a Prescription Drug User Fee Act (PDUFA) date of June 17, 2011.

14 Feb 2011

SynthRx to become wholly-owned subsidiary of ADVENTRX

ADVENTRX Pharmaceuticals, Inc. today announced that it has entered into a definitive agreement to acquire SynthRx, Inc., a private biotechnology company developing a purified form of a rheologic and antithrombotic agent, poloxamer 188.

14 Feb 2011

FDA grants final approval for Hi-Tech Pharmacal's ANDA for levofloxacin ophthalmic solution

Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration granted final approval for the Company's Abbreviated New Drug Application for levofloxacin ophthalmic solution, 0.5% the generic for Vistakon's Quixin ophthalmic solution, which had sales of $2 million for the 12 months ended December 2010 according to IMS sales data.

10 Feb 2011

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

10 Feb 2011

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

Zogenix, Inc. announced today the completion of enrollment in its pivotal Phase 3 efficacy study (Study 801) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

10 Feb 2011

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

10 Feb 2011

BioCryst reports net loss of $9.1M for fourth quarter 2010 vs. $15.2M net income for fourth quarter 2009

BioCryst Pharmaceuticals, Inc. announced financial results for the fourth quarter and full year ended December 31, 2010.

10 Feb 2011

A.P. Pharma provides update on response to APF530 Complete Response Letter

A.P. Pharma, Inc., a specialty pharmaceutical company, today provided an update on its progress toward responding to the Complete Response Letter for APF530 that the Company received from the U.S. Food and Drug Administration (FDA) in March 2010.

9 Feb 2011

Natco Pharma files ANDA with FDA for generic version of Tamiflu

Alvogen, the US-based pharmaceutical company, today announced that its India-based partner, Natco Pharma Limited, has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for the generic version of Tamiflu.

9 Feb 2011

Momenta receives US patent for methods of developing glatiramer acetate drug

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, announced today that on February 8, 2011 the U.S. Patent and Trademark Office issued U.S. Patent No. 7,884,187, entitled "Analysis of Amino Acid Copolymer Compositions."

9 Feb 2011

Natco Pharma submits ANDA to FDA for generic version of Tamiflu 75 mg capsules

Gilead Sciences, today announced receipt of a Paragraph IV Certification Notice Letter advising that Natco Pharma Limited submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration requesting permission to manufacture and market a generic version of Tamiflu 75 mg capsules.

7 Feb 2011

AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder

AstraZeneca and Targacept, Inc. today announced initiation of a Phase 2b clinical trial of TC-5214, a nicotinic channel blocker, as a "switch" monotherapy treatment for patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant therapy. This study is in addition to the companies' Phase 3 RENAISSANCE Program for TC-5214 as an adjunctive treatment for MDD.

7 Feb 2011

Progenics, Salix enter exclusive worldwide license agreement for RELISTOR

Progenics Pharmaceuticals, Inc. and Salix Pharmaceuticals, Ltd. today announced that they have entered into an exclusive worldwide (except Japan) agreement by which Salix has licensed rights to RELISTOR® (methylnaltrexone bromide).

7 Feb 2011

AMRI fourth quarter total revenue increases 12% to $48.6 million

AMRI today reported financial and operating results for the fourth quarter and full year ended December 31, 2010.

7 Feb 2011

FDA approves ANDA for phentermine HCl 37.5 mg tablets

Elite Pharmaceuticals, Inc. announced today the approval of an Abbreviated New Drug Application for phentermine HCl 37.5 mg tablets by the U.S. Food and Drug Administration. The phentermine HCl tablets are the generic equivalent of the Adipex-P 37.5 mg tablets.

4 Feb 2011

Merck reports GAAP net income of $861 million for 2010

Merck, known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the fourth quarter of $0.88, which excludes purchase accounting adjustments, restructuring costs and merger-related expenses.

4 Feb 2011

New Drug Application News and Research

FDA waives NDA filing fee for Antares' Anturol NDA

Neoprobe achieves accrual goal in Lymphoseek Phase 3 study in breast cancer/melanoma

Tarsa completes oral calcitonin Phase III trial for treatment of postmenopausal osteoporosis

Positive results from Glenmark's crofelemer Phase 2 study in acute watery diarrhea

FDA accepts King's ACUROX NDA for filing with Priority review classification

SynthRx to become wholly-owned subsidiary of ADVENTRX

FDA grants final approval for Hi-Tech Pharmacal's ANDA for levofloxacin ophthalmic solution

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

BioCryst reports net loss of $9.1M for fourth quarter 2010 vs. $15.2M net income for fourth quarter 2009

A.P. Pharma provides update on response to APF530 Complete Response Letter

Natco Pharma files ANDA with FDA for generic version of Tamiflu

Momenta receives US patent for methods of developing glatiramer acetate drug

Natco Pharma submits ANDA to FDA for generic version of Tamiflu 75 mg capsules

AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder

Progenics, Salix enter exclusive worldwide license agreement for RELISTOR

AMRI fourth quarter total revenue increases 12% to $48.6 million

FDA approves ANDA for phentermine HCl 37.5 mg tablets

Merck reports GAAP net income of $861 million for 2010

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