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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

Myeloma cancer drug gets the green light from the EU

The European Union has given the green light to a drug which doubles the survival rates for people with myeloma.

21 Jun 2007

Medicare Part D plans vary across U.S.

An examination of Medicare Part D plans in California and Hawaii reveals wide variations in drug formularies, but indicates that for many classes of drugs, it is possible to find at least one or more drug that is covered by nearly all Part D plans, according to a study in the June 20 issue of JAMA: The Journal of the American Medical Association

20 Jun 2007

Bristol-Myers Squibb granted NDA for ixabepilone

Bristol-Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the New Drug Application (NDA) for the investigational compound ixabepilone, an epothilone B analog.

20 Jun 2007

Reports of abnormal behaviour sends Tamiflu back to the drawing board

The manufacturers of the bird flu drug Tamiflu are about to repeat basic research and clinical trials on the high profile influenza drug.

20 Jun 2007

New database tells which sunscreens are safe and effective

According to a nonprofit research organization in the United States not all sunscreens offer adequate protection from the sun's harmful rays and some can in fact harm the skin.

20 Jun 2007

Orphan drug status granted to Immtech for malaria treatment pafuramidine

Immtech Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for pafuramidine (DB289) for the treatment of malaria.

19 Jun 2007

Alli hits the stores

The first non-prescription diet drug ever to be approved by the FDA hit the shops this week and optimistic dieters are dashing out to buy it.

19 Jun 2007

OTC diet pill Alli now on sale in the U.S.

The first and only over-the-counter (OTC) product for weight loss approved by the Food and Drug Administration (FDA) has gone on sale in the U.S.

18 Jun 2007

Lupin announces FDA approval of Trandolapril tablets

Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1mg, 2mg and 4mg. Commercial shipments of Trandolapril tablets have commenced.

17 Jun 2007