Pharmaceutical news: News about clinical trial, new launches, NDA, ANDA

Roche Announces Shipments of New Supplies of Childrens Tamiflu in the U.S

Jan 30, 2010

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has begun shipping additional quantities of Tamiflu® (oseltamivir phosphate) oral suspension (liquid). The added supplies of Tamiflu will begin arriving in

KemPharm, Inc. Announces Positive Results from Phase 1 Trial of KP106 for ADHD

Jan 30, 2010

KemPharm, Inc. today announced positive results from a Phase 1 clinical trial of KP106, its novel prodrug for attention-deficit hyperactivity disorder (ADHD). KP106, a new chemical entity (NCE) composed of the active

Alli 60 mg capsules 120 count refill kit Counterfeit Product

Jan 20, 2010

FDA notified consumers and healthcare professionals about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). The counterfeit version contained the controlled substance sibutramine and did not contain orlistat, the active

VIVUS Announces Additional Results of Phase 3 avanafil Study in Erectile Dysfunction Showing Efficac

Jan 12, 2010

VIVUS,Inc. (Nasdaq: VVUS) today announced new data from an analysis of the recently completed phase 3 study (REVIVE TA-301) of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED). Patients who attempted

Aurobindo Pharma receives final approval for Cetirizine Hydrochloride Syrup

Jan 12, 2010

Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Cetirizine Hydrochloride Syrup 1mg/mL (ANDA No 090751) from the US Food & Drug Administration (USFDA). This approval

The Medicines Company Issues a Nationwide Recall for Certain Lots of Cleviprex

Jan 12, 2010

The Medicines Company (NASDAQ: MDCO) announced today that it is voluntarily recalling eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which

Mcneil Consumer Healthcare Announces A Voluntary Nationwide Recall

Jan 08, 2010

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall to include all available product lots of TYLENOL

ADVENTRX Pharmaceuticals Submits ANX 530 New Drug Application

Jan 08, 2010

PRNewswire-FirstCall via COMTEX/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate

AstraZeneca Reaches Agreements With Teva Pharmaceuticals

Jan 08, 2010

AstraZeneca announced today that it has entered into an agreement with Teva Pharmaceutical Industries Ltd. and affiliates (collectively “Teva”) to settle patent litigation regarding Teva’s proposed generic version of AstraZeneca’s Nexium

Dr. Reddys and Rheoscience announce results from First Phase III clinical trial of Balaglitazone

Jan 08, 2010

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) and Rheoscience, a subsidiary of Nordic Bioscience A/S, today announced the headline results from the first phase III study for their investigational agent, Balaglitazone. The study (Study 307) was a phase III