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Barr receives approval for generic KYTRIL tablets

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s KYTRIL (granisetron hydrochloride) Tablets, 1mg (eq to 1 mg base).

3 Jan 2008

AstraZeneca submits sNDAs for SEROQUEL XR for bipolar symptoms

AstraZeneca has announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

3 Jan 2008

Perrigo receives FDA OK for OTC Cetirizine Hydrochloride tablets

Perrigo Company has announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.

2 Jan 2008

Mylan announces FDA approval for Cetirizine Hydrochloride tablets

Mylan Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.

2 Jan 2008

Ensuring heart safety of non-heart drugs

Current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of drugs developed primarily for non-cardiovascular medical problems, according to a recent presentation made by Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City.

2 Jan 2008

FDA approves Voluven for blood loss post surgery

The U.S. Food and Drug Administration has approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.

28 Dec 2007

Novavax's new bird flu vaccine could bolster the arsenal against a pandemic

The drug company Novavax has announced that it's experimental avian flu vaccine has proved to be both safe and effective in Phase I/IIa trials in humans.

20 Dec 2007

More warnings about anti smoking drug Champix

The European drugs regulator, the European Medicines Agency (EMEA) is calling for warnings to be placed on the the anti smoking drug Champix (varenicline).

20 Dec 2007

Authorities in the U.S. say hold back on children's Hib vaccine

Health authorities in U.S. are advising doctors to defer giving booster shots of a childhood vaccine following suspicions that production equipment may not have been properly sterilized.

20 Dec 2007

Anthrax vaccine will add to America's arsenal against bioterrorism

A company, based in Rockville, Maryland in the USA, with the help of government funding, has used the human genome to develop a vaccine that may give protection from anthrax.

19 Dec 2007

FDA warns vaginal contraceptive offers no protection against AIDS

The U.S. Food and Drug Administration has decreed that the over-the-counter vaginal contraceptive and spermicidal product Nonoxynol-9, or N9, must carry a warning about its use.

19 Dec 2007

Thyroid cancer drug given expanded approval by FDA

The U.S. Food and Drug Administration (FDA) has given expanded approval for a drug used to treat thyroid cancer.

19 Dec 2007

New scheme to revolutionise system of prescribing medicines

Patients could be saved millions of trips to their GP under a new scheme that has the potential to revolutionise the system of prescribing medicines.

18 Dec 2007

Oral diabetes medication - new guidelines

A pair of plain-language guides that outline the latest scientific evidence on the effectiveness and safety of oral medications for adults with type 2 diabetes are now available from HHS' Agency for Healthcare Research and Quality.

18 Dec 2007

Eli Lilly and BioMS Medical announce licensing and development agreement

Eli Lilly and Company and BioMS Medical Corp. have announced that the two companies have entered into a licensing and development agreement granting Lilly exclusive worldwide rights to BioMS Medical's lead multiple sclerosis (MS) compound, MBP8298.

18 Dec 2007

NCPA applauds pharmacy tricare provisions in the congressional passage of the defense authorization bill

The National Community Pharmacists Association (NCPA) thanks Congress for including key pharmacy provisions in the Defense Authorization Act Conference Report for fiscal year 2008 it passed last week.

17 Dec 2007

New principle for developing vaccines

Infections with a certain type of bacteria (group B streptococcus) can lead to severe, sometimes life-threatening, infections in newborn infants.

14 Dec 2007

BioMarin Pharmaceutical announces FDA approval for Kuvan

BioMarin Pharmaceutical Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU).

14 Dec 2007

GlaxoSmithKline response to JAMA article on ICES retrospective analysis

The following is GlaxoSmithKline's response to the retrospective analysis by the Institute for Clinical Evaluative Sciences (ICES) titled "Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes".

13 Dec 2007