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FDA approves Matrix's generic Protonix DR Tablets ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-release (DR) Tablets USP, 20 mg (base) and 40 mg (base), the generic version of Wyeth's Protonix® DR Tablets, a treatment for the irritation of the esophagus caused by gastroesophageal reflux disease (GERD).

25 Jan 2011

FDA accepts Optimer's fidaxomicin NDA for filing

Optimer Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI.

24 Jan 2011

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

Boehringer Ingelheim's Prazaxa receives Japanese approval for stroke prevention in AF patients

The Ministry of Health, Labour and Welfare in Japan today approved dabigatran etexilate, Boehringer Ingelheim's novel, oral direct thrombin inhibitor under the brand name Prazaxa for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation marking the first approval of a novel oral anticoagulant in the Asia-Pacific region and specifically Japan in nearly 50 years.

24 Jan 2011

Watson predicts $4.2 billion in revenues from Global Generics and Global Brand businesses

During an investor meeting held today in New York, NY, Watson Pharmaceuticals, Inc. provided an update on its Global businesses, including a detailed overview of its commercial operations and pipeline developments within its Global Generics and Global Brands businesses, and an update of achievements within its Global Operations. In conjunction with the meeting, the Company provided its preliminary 2011 financial and long term growth forecasts.

21 Jan 2011

VIVUS holds End-of-Review meeting with FDA for QNEXA NDA

VIVUS, Inc. today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational drug for the treatment of obesity. The meeting occurred on January 19th at the FDA's offices in Maryland and was attended by senior members of the FDA and VIVUS' management and consultants.

21 Jan 2011

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C.

20 Jan 2011

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine and Zidovudine Tablets, 30 mg/60 mg.

20 Jan 2011

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

ADVENTRX Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA).

20 Jan 2011

Transcept announces Intermezzo NDA resubmission for treatment of middle of the night awakenings

Transcept Pharmaceuticals, Inc. today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Intermezzo® for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

18 Jan 2011

Alexza completes FDA review for AZ-004 NDA

Alexza Pharmaceuticals, Inc. announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.

18 Jan 2011

Mylan receives FDA approval for generic Precose 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 Acarbose Tablets, 25 mg, 50 mg and 100 mg, the generic version of Bayer's Precose® Tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes.

18 Jan 2011

Pfizer initiates rolling submission of crizotinib NDA for ALK-positive advanced NSCLC

Pfizer Inc. announced today that it has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for crizotinib (PF-02341066), an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive. Pfizer expects to complete the submission in the first half of 2011.

13 Jan 2011

K-V Pharmaceutical provides update on FDA review of NDA for Gestiva

K-V Pharmaceutical Company today issued an update on the status of the U.S. Food and Drug Administration's review of Hologic, Inc.'s New Drug Application for Gestiva as a treatment for the prevention of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

12 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Amarin completes public offering at $7.60 per ADS

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that it has completed its previously announced underwritten public offering of American Depositary Shares at a price to the public of $7.60 per ADS.

11 Jan 2011

LibiGel may be the first FDA approved product to treat HSDD in menopausal women

BioSante Pharmaceuticals, Inc., a pharmaceutical company developing products for the treatment of female sexual health, today announced results of a survey of over 100 Obstetrician/Gynecologists and Primary Care Physicians regarding the need for an FDA-approved drug to treat a form of Female Sexual Dysfunction (FSD) known as Hypoactive Sexual Desire Disorder (HSDD).

11 Jan 2011

IGI Laboratories submits second abbreviated new drug application to FDA

IGI Laboratories, a New Jersey based formulation and manufacturing company, today announced that it has submitted its second abbreviated new drug application to the US FDA.

10 Jan 2011

Watson receives FDA approval for generic Fentora

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Fentanyl Buccal tablets, USP, in the 0.1, 0.2, 0.4, 0.6 and 0.8 mg strengths, the generic equivalent to Cephalon's Fentora ® tablets.

10 Jan 2011

New Drug Application News and Research

FDA approves Matrix's generic Protonix DR Tablets ANDA

FDA accepts Optimer's fidaxomicin NDA for filing

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

SuppreMol completes successful pre-IND meeting with U.S. FDA

Boehringer Ingelheim's Prazaxa receives Japanese approval for stroke prevention in AF patients

Watson predicts $4.2 billion in revenues from Global Generics and Global Brand businesses

VIVUS holds End-of-Review meeting with FDA for QNEXA NDA

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

Transcept announces Intermezzo NDA resubmission for treatment of middle of the night awakenings

Alexza completes FDA review for AZ-004 NDA

Mylan receives FDA approval for generic Precose Tablets ANDA

Pfizer initiates rolling submission of crizotinib NDA for ALK-positive advanced NSCLC

K-V Pharmaceutical provides update on FDA review of NDA for Gestiva

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Amarin completes public offering at $7.60 per ADS

LibiGel may be the first FDA approved product to treat HSDD in menopausal women

IGI Laboratories submits second abbreviated new drug application to FDA

Watson receives FDA approval for generic Fentora

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