Content about Food and Drug Administration

October 4, 2010

Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug...

NEW YORK Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug made by Eisai, according to published reports.

Bloomberg reported Tuesday that the Indian drug maker had won 180 days’ exclusivity in which to market a generic version of Eisai’s Aricept (donepezil hydrochloride) tablets, pending final Food and Drug Administration approval, beating out Israel-based Teva Pharmaceutical Industries.

October 4, 2010

Generic drug maker Watson Pharmaceuticals is seeking approval for a generic treatment for Parkinson’s disease,...

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals is seeking approval for a generic treatment for Parkinson’s disease, prompting a lawsuit from the drug’s manufacturer.

 

Watson said Tuesday that Watson Labs, a subsidiary of the company, had filed for approval for rasagiline mesylate tablets, a treatment for Parkinson’s used either alone or with the drug levodopa. The drug is a generic version of Teva Neuroscience’s Azilect.

 

 

October 3, 2010

The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson...

RARITAN, N.J. The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson for a drug to treat chronic pain, J&J said Monday.

 

October 3, 2010

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

PITTSBURGH The Food and Drug Administration has approved a generic chemotherapy drug made by Mylan.

 

The Pittsburgh-based drug maker said Monday that it had received approval for the injected drug fludarabine phosphate in the 25-mg-per-mL strength. The FDA determined the drug to be therapeutically equivalent to Teva Parenteral’s fludarabine phosphate.

 

 

October 3, 2010

The Food and Drug Administration has awarded almost $3 million for tuberculosis research, the agency...

October 3, 2010

The Food and Drug Administration has approved a nonstimulant drug for treating attention deficit hyperactivity...

FLORHAM PARK, N.J. The Food and Drug Administration has approved a nonstimulant drug for treating attention deficit hyperactivity disorder.

 

Shionogi announced Monday the approval of Kapvay (clonidine hydrochloride), an extended-release drug for treating ADHD in children and adolescents ages 6 to 17 years. The company said Kapvay was the only formulation of clonidine hydrochloride approved for treating ADHD and the first ADHD treatment approved for use as an add-on therapy to stimulant drugs.

 

 

September 30, 2010

The Food and Drug Administration is cracking down on companies that sell an unapproved treatment...

September 30, 2010

McNeil products soon will repopulate shelves, Johnson & Johnson chairman and CEO Bill Weldon shared...

WASHINGTON McNeil products soon will repopulate shelves, Johnson & Johnson chairman and CEO Bill Weldon shared on Thursday during his testimony before the House of Representatives Committee on Oversight and Government Reform.

 

September 29, 2010

The biotech division of Johnson & Johnson is hoping to expand the use of a...

HORSHAM, Pa. The biotech division of Johnson & Johnson is hoping to expand the use of a treatment for autoimmune disorders.

 

Centocor Ortho Biotech said it had filed an application with the Food and Drug Administration to get approval for Simponi (golimumab) to stop the progression of structural damage, induce major clinical response, maintain reductions in signs and symptoms, and improve physical function in the treatment of rheumatoid arthritis.

 

 

September 29, 2010

The Food and Drug Administration has given tentative approval to a generic cholesterol drug made...

MUMBAI, India The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Sun Pharmaceutical Industries.

Sun announced Wednesday the tentative approval of rosuvastatin calcium tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths.

September 29, 2010

The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker...

JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.

 

Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.

 

 

Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.

 

September 28, 2010

Abbott has received market clearance from the Food and Drug Administration for RevitaLens Ocutec, a...

ABBOTT PARK, Ill. Abbott has received market clearance from the Food and Drug Administration for RevitaLens Ocutec, a multipurpose disinfecting solution for silicone hydrogel and conventional soft contact lenses.

September 28, 2010

Keryx has begun its phase-3 clinicial trial of a drug designed to treat elevated serum...

NEW YORK Keryx has begun its phase-3 clinicial trial of a drug designed to treat elevated serum phosphorous levels in patients with end-stage renal disease on dialysis.

September 27, 2010

The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture...

SILVER SPRING, Md. The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. According to the FDA, these claims suggested the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to: Johnson & Johnson (Listerine total care anti-cavity mouthwash), CVS (CVS complete care anti-cavity mouthwash), and Walgreens (Walgreen mouth rinse full action).

September 27, 2010

GlaxoSmithKline Consumer Healthcare is urging the Food and Drug Administration to remove smokeless tobacco products...

PARSIPPANY, N.J. GlaxoSmithKline Consumer Healthcare is urging the Food and Drug Administration to remove smokeless tobacco products from the market.

September 27, 2010

The Food and Drug Administration has approved a generic version of a drug for a...

MUMBAI, India The Food and Drug Administration has approved a generic version of a drug for a devastating muscular disorder.

 

Sun Pharmaceutical Industries announced Tuesday the approval of riluzole hydrochloride in the 50-mg strength. The tablets are used to treat amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease.

 

 

The drug is a generic version of Sanofi-Aventis’ Rilutek, which has sales of around $50 million, according to Sun.

 

September 26, 2010

Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon...

September 26, 2010

The Food and Drug Administration has approved a new oral contraceptive from Bayer HealthCare Pharmaceuticals....

SILVER SPRING, Md. The Food and Drug Administration has approved a new oral contraceptive from Bayer HealthCare Pharmaceuticals.

 

The FDA announced Friday the approval of Beyaz (estrogen and progestin) tablets. The pills also contain a folate known as levomefolate calcium. Low folate levels in the body are associated with such conditions as spina bifida, and physicians recommend that women of childbearing age supplement their diets with folate.

 

 

September 26, 2010

More than a dozen top Food and Drug Administration officials will meet with generic drug...

September 26, 2010

Federal efforts to simplify and standardize the information that patients receive with their prescription medications...

September 26, 2010

Winc Design is launching its Charlie Banana brand of environmentally friendly cloth diapers and baby...

Like a freighter in the Atlantic Ocean during hurricane season, anyone with a stake in the generic drug industry will encounter smooth and bumpy sailing alike over the next few years, according to a recent presentation by an industry expert.

September 26, 2010

The generics subsidiary of Pfizer is launching a new business focused on authorized generics. Greenstone...

PEAPACK, N.J. —The generics subsidiary of Pfizer is launching a new business focused on authorized generics. Greenstone announced the launch of the Authorized Generics Alliance, which it said would combine its business model and 17 years of experience in the generics market with the expertise of other drug makers to market authorized generics in the United States under the Greenstone label.

September 26, 2010

Greenstone announced the launch of an authorized generic version of the Alzheimer’s disease drug Aricept...

September 23, 2010

An investigational diabetes drug works as well as a generic already on the market, according...

STOCKHOLM An investigational diabetes drug works as well as a generic already on the market, according to results of a late-stage clinical trial announced Friday by AstraZeneca and Bristol-Myers Squibb.

 

September 22, 2010

The Food and Drug Administration has approved a manufacturing plan for a drug to treat...

EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.

 

Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.