New Drug Application News and Research

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ANDA approved for Losartan Potassium Tablets USP, Losartan Potassium and Hydrochlorothiazide Tablets

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application for Losartan Potassium Tablets USP, 25mg, 50mg and 100mg as well as Losartan Potassium and Hydrochlorothiazide Tablets, 50mg/12.5mg and 100mg/25mg by the U.S. Food and Drug Administration. Both products are available for immediate shipment to wholesalers and pharmacies nationwide.

7 Oct 2010

Roche receives development and commercialization rights for danoprevir drug

InterMune, Inc. today announced that it has sold worldwide development and commercialization rights to danoprevir (also known as RG7227 or ITMN-191) to Hoffman-La Roche Inc. and F. Hoffman-La Roche Ltd. for $175 million in cash.

7 Oct 2010

Neoprobe completes pre-NDA assessment for Lymphoseek with FDA

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has completed a pre-NDA assessment for Lymphoseek with the U.S. Food and Drug Administration (FDA).

7 Oct 2010

CoreLab Partners completes first ever regulatory mandated Thorough QT study in the Asia Pacific Rim

CoreLab Partners, Inc, the global entity resulting from the merger between RadPharm and Medifacts International in February of this year, has recently completed the first ever regulatory mandated Thorough QT (TQT) study conducted in the Asia Pacific Rim and the first TQT study for a Japanese new drug application (NDA).

6 Oct 2010

Aeterna Zentaris' AEZS-130 demonstrates potential as oral diagnostic test for AGHD

Aeterna Zentaris Inc., today announced that an interim review of a Phase 3 trial of AEZS-130 (macimorelin, SolorelTM), demonstrates the compound may provide a simple, well-tolerated and safe oral diagnostic test for Adult Growth Hormone Deficiency (AGHD). The data was presented earlier today by Beverly M.K. Biller, M.D. of the Harvard Medical School/Massachusetts General Hospital in Boston, at the 5th International Congress of the Growth Hormone Research Society (GRS) and the Insulin-like Growth Factors (IGF) Society in New York City.

6 Oct 2010

Watson seeks FDA approval to market rasagiline mesylate tablets

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market rasagiline mesylate 0.5 and 1.0 mg tablets.

6 Oct 2010

Saneron receives grant to develop safety guidelines for transplanting HUBC cells in Alzheimer's disease

The National Institutes of Health has awarded a three-year, $2.6-million grant to the University of South Florida and Tampa-based biotechnology company Saneron-CCEL Therapeutics, Inc., to establish dosing and safety guidelines for transplanting human umbilical cord blood cells (HUBC) into animal models of Alzheimer's disease.

6 Oct 2010

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

6 Oct 2010

Tris Pharma receives FDA final approval for generic Tussionex ANDA

Par Pharmaceutical Companies, Inc. today announced that its licensing partner, Tris Pharma, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for hydrocodone polistirex and chlorpheniramine polistirex (CIII) extended-release (ER) oral suspension (equivalent to 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate per 5 mL).

5 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

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 Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

FDA announces dates for public hearing on Biologics Price Competition and Innovation Act of 2009

The U.S. Food and Drug Administration has scheduled a two-day public hearing on Nov. 2-3, 2010, on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31, room 1503, in Silver Spring, Md.

4 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced the Company has completed patient enrollment in its pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. Agile's NEW CHOICE Study enrolled 1500 women at over 100 sites throughout the U.S. The study is comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive.

4 Oct 2010

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Mylan subsidiary receives FDA approval for Fludarabine Phosphate Injection ANDA

Mylan Inc. today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL).

4 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

QRxPharma's A$14 million Placement oversubscribed

QRxPharma Limited has today announced a Placement which raised A$14 million and which was significantly oversubscribed.

1 Oct 2010

New Drug Application News and Research

ANDA approved for Losartan Potassium Tablets USP, Losartan Potassium and Hydrochlorothiazide Tablets

Roche receives development and commercialization rights for danoprevir drug

Neoprobe completes pre-NDA assessment for Lymphoseek with FDA

CoreLab Partners completes first ever regulatory mandated Thorough QT study in the Asia Pacific Rim

Aeterna Zentaris' AEZS-130 demonstrates potential as oral diagnostic test for AGHD

Watson seeks FDA approval to market rasagiline mesylate tablets

Saneron receives grant to develop safety guidelines for transplanting HUBC cells in Alzheimer's disease

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Tris Pharma receives FDA final approval for generic Tussionex ANDA

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

FDA announces dates for public hearing on Biologics Price Competition and Innovation Act of 2009

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Mylan subsidiary receives FDA approval for Fludarabine Phosphate Injection ANDA

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

QRxPharma's A$14 million Placement oversubscribed

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