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Actavis launches Ondansetron tablets in the U.S.

Actavis Group has announced that it has launched Ondansetron Tablets in the U.S. Actavis will market the product under an agreement with Natco Pharma Limited. Distribution of the product will commence immediately.

28 Jun 2007

Barr announces tentative approval for generic version of Effexor tablets

Barr Pharmaceuticals, Inc. has announced that its subsidiary PLIVA has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Wyeth Pharmaceuticals Inc.'s Effexor (Venlafaxine Hydrochloride) Tablets, 25mg, 37.5mg, 50mg, 75mg and 100mg.

27 Jun 2007

AMA says in-store health clinics put patients in danger

The American Medical Association (AMA) has raised questions about the service offered by in-store health clinics.

26 Jun 2007

Roche makes offer to acquire Ventana Medical Systems

Roche will make a tender offer to acquire all outstanding shares of common stock of Ventana Medical Systems for $75.00 per share in cash, or an aggregate of approximately $3 billion on a fully diluted basis.

From Roche Sequencing and Life Science 26 Jun 2007

Abuse of prescription drugs

Increasingly, drug abusers are getting their next fix from their medicine cabinets, instead of from drug dealers.

26 Jun 2007

Mylan receives FDA approval for Ondansetron tablets

Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Hydrochloride (HCl) Tablets, 4 mg (base), 8 mg (base) and 24 mg (base), and Ondansetron Orally Disintegrating Tablets (ODT) USP, 4 mg and 8 mg.

26 Jun 2007

SYMBICORT now available in the U.S. for asthma

AstraZeneca has announced today that SYMBICORT (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler (pMDI) is now available in the United States for the long-term maintenance treatment of asthma in patients 12 years of age and older.

26 Jun 2007

FDA cracks down on dietary supplements

It's taken a few years but the Food and Drug Administration (FDA) in the U.S. has finally established a set of regulations to ensure good manufacturing practices for dietary supplements.

25 Jun 2007

Green light for first drug to treat fibromyalgia

Authorities in the United States have given approval for the first drug to treat the condition fibromyalgia.

25 Jun 2007

Ranbaxy receives tentative FDA approval for Tamsulosin capsules

Ranbaxy Pharmaceuticals has announced that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Tamsulosin Hydrochloride Capsules, 0.4 mg.

23 Jun 2007

U.S. FDA approves Lyrica (pregabalin), the first drug to treat fibromyalgia

The U.S. Food and Drug Administration has approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.

23 Jun 2007

FDA clears computerized medication box

The U.S. Food and Drug Administration has cleared for marketing the INRange Systems' Electronic Medication Management Assistant (EMMA), a programmable device that stores and dispenses prescription medication for patients' use in the home.

23 Jun 2007

Anacor finds novel mechanism for lead anti-fungal drug, AN2690

Anacor Pharmaceuticals, a privately held pharmaceutical company, has announced that the journal Science will publish results of research that details how AN2690, the company's lead clinical candidate, kills fungal cells by interfering with synthesis of a specific protein required for fungal growth.

23 Jun 2007

Ranbaxy receives tentative approval to manufacture Amlodipine Besylate tablets

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base).

23 Jun 2007

FDA approves Differin (adapalene) gel, 0.3% for acne

Galderma Laboratories, L.P., has announced that the U.S. Food and Drug Administration (FDA) has approved Differin (adapalene) Gel, 0.3%, a new, higher concentration formulation of Differin (adapalene) 0.1%, a topical retinoid indicated for the treatment of acne.

23 Jun 2007

Genzyme files for FDA approval of single-treatment Synvisc-One

Genzyme Corp. has announced that it has filed with the U.S. Food and Drug Administration (FDA) for approval of Synvisc-One, the single treatment of Synvisc (hylan G-F 20) that provides up to six months of pain relief from osteoarthritis (OA) of the knee.

23 Jun 2007

New trade agreement language to allow developing countries more flexibility in circumventing drug patents, other restrictions

Democratic lawmakers and U.S. trade officials are in the final stages of negotiation over language to be added to international free trade agreements that would allow developing countries more flexibility in circumventing drug patents and other restrictions on pharmaceuticals, sources said recently, CongressDaily reports.

22 Jun 2007

Texas sues three drug makers alleging Medicaid fraud

Texas on Wednesday filed lawsuits against Mylan Laboratories, Sandoz, Teva Pharmaceuticals and subsidiaries of those companies alleging that the state Medicaid program overpaid retailers by at least tens of millions of dollars for medications because the companies did not disclose discounts they were providing to retailers, the Houston Chronicle reports.

22 Jun 2007

House Committee passes prescription drug user fee act reauthorization legislation

The House Energy and Commerce Committee on Thursday voted 39-0 to approve nine bills that would expand FDA's authority to regulate prescription drug safety and increase user fees paid by drug and medical device companies, Dow Jones reports.

22 Jun 2007

FDA makes final ruling on dietary supplements

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements.

22 Jun 2007