Content about Generic drug

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 8, 2013

The United States is leading in its preference for generic drugs. According to a new report by Rhinebeck, N.Y.-based Phoenix Marketing International, 37% of American consumers expressed a preference for generic drugs when they were available, compared with 22% of the French, 21% of Canadians and 12% of Britons. The study was based on 810 consumers in the four countries.

The United States is leading in its preference for generic drugs. According to a new report by Rhinebeck, N.Y.-based Phoenix Marketing International, 37% of American consumers expressed a preference for generic drugs when they were available, compared with 22% of the French, 21% of Canadians and 12% of Britons. The study was based on 810 consumers in the four countries.

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

 

November 1, 2013

Indian drug maker Dr. Reddy's Labs had sales of $536 million in second quarter 2014 and profits of $110 million, the company said.

HYDERABAD, India — Indian drug maker Dr. Reddy's Labs had sales of $536 million in second-quarter 2014 and profits of $110 million, the company said.

Those figures represented sales growth of 17% and a 76% growth in profits over second quarter 2013. Seventy-nine percent of the company's sales came from generic drugs, including 50% from sales in North America; sales of generics grew by 32% over last year.

November 1, 2013

Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

PITTSBURGH — Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

November 1, 2013

Teva Pharmaceutical Industries had $5.1 billion in sales and $711 million in profits in third-quarter 2013, the Israeli drug maker said.

JERUSALEM — Teva Pharmaceutical Industries had $5.1 billion in sales and $711 million in profits in third-quarter 2013, the Israeli drug maker said.

October 31, 2013

Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

DUBLIN — Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

The drug maker said it had filed with the FDA for approval of isotretinoin capsules in the 10-mg, 20-mg, 30-mg and 40-mg strengths. The drug is a generic version of Ranbaxy's Absorica, a retinoid used to treat severe, recalcitrant nodular acne in patients 12 and older.

October 29, 2013

In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

October 29, 2013

Ranbaxy Labs had global sales of $447.6 million in third quarter 2013, compared with $434.6 million in third quarter 2012, the Indian drug maker said Tuesday.

GURGAON, India — Ranbaxy Labs had global sales of $447.6 million in third quarter 2013, compared with $434.6 million in third quarter 2012, the Indian drug maker said Tuesday.

Sales from generics were $208.4 million, while branded and OTC drugs had sales of $239.3 million North American sales were $143.24 million including $128.6 million in the United States, lower than in Q3 2012 due to a large contribution last year from new generic drugs.

October 29, 2013

Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

October 25, 2013

Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.

NEW YORK — Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 22, 2013

The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

The FDA approved a generic version of Mission Pharmacal's Tindamax (tinidazole) made by Unique Pharmaceuticals. The drug is a tablet in the 250-mg and 500-mg strengths.

Tindamax is used to treat bacterial vaginosis, trichomoniasis and giardiasis. The drug has annual sales of about $16.2 million, according to IMS Health.

 

October 17, 2013

As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

October 17, 2013

Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.

PITTSBURGH — Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.

Glinka's appointment becomes effective Dec. 2. Before joining Mylan, he was CEO of Polpharma Group from 2003 to 2006 and again from 2009 until this year, helping the company expand from a small, local company to a leading drug company in central and eastern Europe, the Caucasus and Central Asia. The company became a leader in the Polish market and doubled its sales to more than $1 billion between 2011 and 2013.

October 17, 2013

Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.

CINCINNATI — Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.

The company, which focuses on authorized generic drugs, announced the deal for lanthanum carbonate chewable tablets in the 500-mg, 750-mg and 1,000-mg strengths. The drug is a version of Shire's Fosrenol. Authorized generics are branded drugs marketed under their generic names at a discounted price, usually through a third-party company under contract with the branded drug's manufacturer.

October 15, 2013

Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

DUBLIN — Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

The generic drug maker said it had filed a regulatory approval application with the Food and Drug Administration for buprenorphine hydrochloride and naloxone hydrochloride sublingual film in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The drug is a generic version of Reckitt Benckiser's Suboxone.

October 15, 2013

The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

JERUSALEM — The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

The Israeli drug maker announced the approval of the antibiotic drug tobramycin inhalation solution, a generic version of Novartis' Tobi.

Tobi has sales of about $350 million during the 12-month period that ended in June, according to IMS Health.

 

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

SILVER SPRING, Md. – One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

In a memo sent out to staff, Center for Drug Evaluation and Research director Janet Woodcock wrote that she would not retire, but was becoming "more deeply involved" in such activities as proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

October 8, 2013

Consumers in the United States are more likely than those in three other countries to say they prefer to receive generic drugs over branded drugs, according to a new study.

RHINEBECK, N.Y. — Consumers in the United States are more likely than those in three other countries to say they prefer to receive generic drugs over branded drugs, according to a new study.

The study, by Phoenix Marketing International, included 810 consumers from the United States, Canada, the United Kingdom and France. Among respondents, 37% of American consumers expressed a preference for generics when they were available, compared with 22% of those in France, 12% in the United Kingdom and 21% in Canada.

October 7, 2013

An analysis by the New York Times published over the weekend makes the case for generic drugs.

NEW YORK — An analysis by the New York Times published over the weekend makes the case for generic drugs.

Times reporter Katie Thomas opened the analysis Saturday by recalling an episode of the Netflix series "Orange Is the New Black," in which the prison saves money by switching inmates to generic drugs, much to their dismay. But that bit of artistic license on the part of the show's writers is evidence of the negative perceptions of generic drugs among the public.

October 1, 2013

Generic drug maker Teva Pharmaceutical Industries has launched a version of a drug used to treat a parathyroid disorder related to kidney disease.

JERUSALEM — Generic drug maker Teva Pharmaceutical Industries has launched a version of a drug used to treat a parathyroid disorder related to kidney disease.

Teva announced Tuesday the launch of paricalcitol, a generic version of AbbVie's Zemplar. As the first company to win Food and Drug Administration approval for the drug, Teva has 180 days in which to compete directly with the branded version.

September 30, 2013

Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.