Content about Food and Drug Administration

January 3, 2011

The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

MUMBAI, India — The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

January 3, 2011

The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

TITUSVILLE, N.J. — The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

Tibotec Therapeutics, a subsidiary of J&J, said the FDA approved a 200-mg formulation of Intelence (etravirine) for treating HIV in patients who have taken previous treatments and whose virus has become resistant to antiretroviral drugs.

December 29, 2010

Recent news that the FDA has rejected Teva's application for a new lower-dose version of multiple sclerosis drug Copaxone likely will hold off the emergence of a generic version of the drug.

NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

December 23, 2010

Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

WHITEHOUSE STATION, N.J. — Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

According to the company, Gardasil is the first HPV vaccine on the market available for use in both men and women, and the only one indicated  to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV.

December 23, 2010

The Food and Drug Administration on Wednesday approved Novartis Pharmaceuticals’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure, according to the pharma company.

EAST HANOVER, N.J. — The Food and Drug Administration on Wednesday approved Novartis Pharmaceuticals’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure, according to the pharma company. 

Amturnide combines the only approved direct rennin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

December 23, 2010

The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

MORRISTOWN, N.J. — The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

Watson's new oral contraceptive is positioned as a novel alternative to currently available birth control pills, and the dosing combination and 24-day active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

December 22, 2010

The House of Representatives on Wednesday passed the Food Safety Modernization Act by a vote of 215-144 to wide industry aplomb.

WASHINGTON — The House of Representatives on Wednesday passed the Food Safety Modernization Act by a vote of 215-144 to wide industry aplomb.

The bill now only needs President Barack Obama’s signature to become law.

If signed into law, the food safety bill will require biennial registration of all food manufacturing facilities, will provide the Food and Drug Administration with new authority to mandate food recalls and will require companies to develop food safety plans.

December 21, 2010

An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

LONDON — An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

AstraZeneca has requested the withdrawal of its pending biological license application for motavizumab from the Food and Drug Administration. Motavizumab is an investigational monoclonal antibody that could prevent serious respiratory syncytial virus disease.

AstraZeneca said it will incur a financial impairment charge of $445 million in fourth quarter 2010.

December 20, 2010

Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.

SAN DIEGO — Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.

December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

December 20, 2010

Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

BRISTOL, Tenn. — Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

The two drug makers announced Tuesday the submission for Acurox (oxycodone hydrochloride), an immediate-release tablet for relief of moderate to severe pain.

The tablets use Acura’s aversion technology, designed to deter abuse of the drug by dissolving or crushing the pills.

December 17, 2010

The Food and Drug Administration has approved a new oral contraceptive developed by Bayer.

WAYNE, N.J. — The Food and Drug Administration has approved a new oral contraceptive developed by Bayer.

Safyral is a combination of Yasmin, also developed by Bayer, with 451 mcg levomefolate calcium, which is a B vitamin known as a folate. It is the second oral contraceptive from Bayer that features folate.

December 17, 2010

The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.

A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.

December 16, 2010

Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

December 15, 2010

A prescription cough suppressant should be kept in childproof containers because of its candy-like appearance, the Food and Drug Administration warned Tuesday.

SILVER SPRING, Md. — A prescription cough suppressant should be kept in childproof containers because of its candy-like appearance, the Food and Drug Administration warned Tuesday.

Tessalon (benzonatate) is made by Forest Labs and comes in the form of a round, liquid-filled gelatin capsule. The drug is used to relieve cough in patients older than 10 years of age.

December 15, 2010

The dietary supplement industry’s leading trade associations on Wednesday joined forces with the Food and Drug Administration to support heightened efforts to address public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients.

WASHINGTON — The dietary supplement industry’s leading trade associations on Wednesday joined forces with the Food and Drug Administration to support heightened efforts to address public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients.

December 15, 2010

A new Consumer Reports poll released Monday found that only one-fifth of U.S. adults were aware of having purchased food, medication or a product (other than a car) that was recalled in the past three years.

WASHINGTON — A new Consumer Reports poll released Monday found that only one-fifth of U.S. adults were aware of having purchased food, medication or a product (other than a car) that was recalled in the past three years.

Americans surveyed believed it is important to know about product recalls, but they were not confident that they are getting adequate information delivered to them, the poll also revealed.

December 15, 2010

Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

MORRISTOWN, N.J. — Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

Watson announced Tuesday that it had filed an application with the Food and Drug Administration seeking approval for hydromorphone hydrochloride extended-release tablets in the 8-mg, 12-mg and 16-mg strengths. The drug is a generic version of Mallinckrodt’s Exalgo.

December 14, 2010

The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

December 14, 2010

The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.

The drug maker submitted its application for the long-acting painkiller Exparel (bupivacaine) in September.

The drug is a topical medication for managing pain following surgery. The FDA expects to finish reviewing the application in July 2011.

December 13, 2010

The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

December 13, 2010

Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

DUBLIN — Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

Shire announced that it had filed the suit in the U.S. District Court for the Northern District of California following the two generic drug makers’ filing of an approval application for guanfacine hydrochloride, a version of Shire’s Intuniv, used to treat hypertension.

December 13, 2010

Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

JERUSALEM — Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

Teva said its petition, concerning the drug Copaxone (glatiramer acetate), is based on what it called the inability to establish acceptable “sameness” due to the active ingredient’s complexity.

December 10, 2010

The Food and Drug Administration has approved a generic drug for hypertension made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan.

Mylan announced Friday the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC.

Nifedipine tablets had sales of around $82 million during the 12-month period ended in June, according to IMS Health.

December 8, 2010

A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.

SAN DIEGO — A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.

Orexigen Therapeutics and Takeda Pharmaceutical announced Tuesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.