New Drug Application News and Research

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Arena, Eisai complete lorcaserin NDA end-of-review meeting with FDA

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA).

22 Dec 2010

Delcath completes NDA submission for chemosaturation system

Delcath Systems, Inc. today announced that the Company has submitted the remaining modules of its 505(b)(2) New Drug Application (NDA) for its proprietary chemosaturation system to the U.S. Food & Drug Administration (FDA). The Company had previously submitted Module 4, consisting of literature based non-clinical data, to the FDA in late April 2010. The Company is seeking an indication for the percutaneous intra-arterial administration of melphalan hydrochloride for use in the treatment of patients with metastatic melanoma in the liver.

22 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Intellipharmaceutics International, today announced that it has notified the U.S. Food and Drug Administration that it has not received notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by the brand owner, Wyeth Pharmaceuticals, a wholly-owned subsidiary of Pfizer, for its application to market a generic of Wyeth's Protonix® tablets.

22 Dec 2010

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

Vertex Pharmaceuticals Incorporated today announced a modification of its Phase 2 clinical trial evaluating 12-week, response-guided regimens of its lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

22 Dec 2010

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Incyte Corporation announced today positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a Food and Drug Administration (FDA) Special Protocol Assessment (SPA) Agreement. COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) is a double-blind, placebo-controlled Phase III trial involving 309 patients.

21 Dec 2010

Lilly completes acquisition of Avid

Eli Lilly and Company today announced that it has completed the acquisition of Avid Radiopharmaceuticals, Inc., a privately held company developing novel molecular imaging compounds intended for the detection and monitoring of chronic human diseases. The transaction, first announced on November 8, 2010, has received the approval of Avid stockholders and clearance under the Hart-Scott-Rodino Antitrust Improvements Act. All other closing conditions have also been met.

20 Dec 2010

King submits ACUROX NDA to FDA

King Pharmaceuticals®, Inc. and Acura Pharmaceuticals, Inc. today announced that King has submitted a New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. Food and Drug Administration (FDA), including a request for priority review classification. ACUROX® is an immediate release tablet containing oxycodone HCl intended for the relief of moderate to severe pain.

20 Dec 2010

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

Chelsea Therapeutics International, Ltd. announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration (FDA) and intends to accelerate its new drug application (NDA) for NORTHERA™(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.

20 Dec 2010

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

Inspire Pharmaceuticals, Inc. announced today that the results from its first Phase 3 clinical trial with denufosol tetrasodium for cystic fibrosis (CF), TIGER-1, have been published in the peer-reviewed publication, American Journal of Respiratory and Critical Care Medicine (AJRCCM). Denufosol is an investigational, inhaled, novel ion channel regulator currently in Phase 3 clinical development for the treatment of CF.

20 Dec 2010

Mylan confirms lawsuit by Shionogi Pharma and CIMA LABS relating to generic Orapred ODT ANDA

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Shionogi Pharma Inc. and CIMA LABS INC. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg and 30 mg.

17 Dec 2010

GSK, Impax enter global development, commercialization agreement for PD investigational product, IPX066

GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (Impax), today announced an agreement for the development and commercialization of IPX066, Impax's novel extended release carbidopa-levodopa product, outside the United States and Taiwan. IPX066, an investigational product under development for the treatment of Parkinson's Disease (PD), is currently in Phase III clinical trials.

17 Dec 2010

FDA issues CRL for AstraZeneca's ticagrelor NDA

AstraZeneca announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor (BRILINTA™).

16 Dec 2010

ADVENTRX seeks meeting with FDA to discuss ANX-514 docetaxel emulsion study findings

ADVENTRX Pharmaceuticals, Inc. today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) to schedule a meeting for the purpose of discussing its product candidate ANX-514 (docetaxel emulsion for injection). The FDA is expected to set the meeting date within 60 days of receiving the request from ADVENTRX.

16 Dec 2010

Watson files generic Exalgo ANDA, confirms patent challenge from Mallinckrodt

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Hydromorphone Hydrochloride Extended-release Tablets, 8 mg, 12 mg, and 16 mg.

14 Dec 2010

FDA accepts for filing Pacira's EXPAREL NDA for postsurgical pain management

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, announced today that the New Drug Application (NDA) for EXPAREL™, a long-acting bupivacaine for postsurgical pain management, has been accepted for filing by the U.S. Food and Drug Administration (FDA).

14 Dec 2010

Nektar reports positive results from NKTR-102 Phase 2 study in metastatic breast cancer at CTRC-AACR SABCS

Nektar Therapeutics today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 in patients with metastatic breast cancer during the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). NKTR-102, a novel investigational topoisomerase I inhibitor-polymer conjugate, is Nektar's lead oncology candidate and is being evaluated in multiple cancer indications.

14 Dec 2010

FDA to review Lantheus' DEFINITY sNDA for use in stress echocardiography

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension for use in stress echocardiography.

14 Dec 2010

Arena initiates dosing in APD811 Phase 1 clinical trial for pulmonary arterial hypertension

Arena Pharmaceuticals, Inc. announced today the initiation of dosing in a Phase 1 clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin receptor for the treatment of pulmonary arterial hypertension, or PAH.

10 Dec 2010

FDA approves Mylan's generic Adalat CC Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Bayer's Adalat® CC Tablets, a treatment for hypertension.

10 Dec 2010

New Drug Application News and Research

Arena, Eisai complete lorcaserin NDA end-of-review meeting with FDA

Delcath completes NDA submission for chemosaturation system

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Lilly completes acquisition of Avid

King submits ACUROX NDA to FDA

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

Mylan confirms lawsuit by Shionogi Pharma and CIMA LABS relating to generic Orapred ODT ANDA

GSK, Impax enter global development, commercialization agreement for PD investigational product, IPX066

FDA issues CRL for AstraZeneca's ticagrelor NDA

ADVENTRX seeks meeting with FDA to discuss ANX-514 docetaxel emulsion study findings

Watson files generic Exalgo ANDA, confirms patent challenge from Mallinckrodt

FDA accepts for filing Pacira's EXPAREL NDA for postsurgical pain management

Nektar reports positive results from NKTR-102 Phase 2 study in metastatic breast cancer at CTRC-AACR SABCS

FDA to review Lantheus' DEFINITY sNDA for use in stress echocardiography

Arena initiates dosing in APD811 Phase 1 clinical trial for pulmonary arterial hypertension

FDA approves Mylan's generic Adalat CC Tablets ANDA

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