Content about Pharmaceutical companies

February 15, 2012

Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

SILVER SPRING, Md. — Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

The FDA advised healthcare professionals and patients that a counterfeit version of Genentech's Avastin (bevacizumab) had been distributed in the United States. The agency said the counterfeit versions carried Roche's logo instead of Genentech's and displayed batch numbers starting with B6010, B6011 or B86017.

February 15, 2012

Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the drug maker's efforts to reduce costs for the branded version, a new study suggested.

PHOENIX — Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the drug maker's efforts to reduce costs for the branded version, a new study suggested.

According to a report released Wednesday by Wolters Kluwer Pharma Solutions' inThought research group, while Lipitor (atorvastatin) has 41% of the market share of all dispensed prescriptions of atorvastatin, it has 35% of the payer approval volume.

February 14, 2012

Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

February 9, 2012

The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan's doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott's Doryx.

February 8, 2012

Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

PARSIPPANY, N.J. — Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

February 3, 2012

For all the fears about the patent cliff, at least one disease state seems to be on the up-and-up in terms of new drug development and new products.

WHAT IT MEANS AND WHY IT'S IMPORTANT — For all the fears about the patent cliff, at least one disease state seems to be on the up-and-up in terms of new drug development and new products.

(THE NEWS: FDA approves Bydureon. For the full story, click here.)

February 3, 2012

Teva Pharmaceuticals has launched a generic version of a psychiatric drug, the company said Friday.

NORTH WALES, Pa. — Teva Pharmaceuticals has launched a generic version of a psychiatric drug, the company said Friday.

Teva announced the launch of olanzapine orally disintegrating tablets in the 5-mg, 10-mg, 15-mg and 20-mg strengths in blister packs of 30.

The drug is a generic version of Eli Lilly's Zyprexa Zydis, used to treat schizophrenia and bipolar disorder.


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February 2, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.

February 2, 2012

The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

Mylan announced that it had received tentative approval for a generic version of Pfizer's Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.

February 2, 2012

Prestige Brands on Tuesday announced that it has completed its previously announced purchase of 15-of-the-17 brands it agreed to acquire from GlaxoSmithKline.

IRVINGTON, N.Y. — Prestige Brands on Tuesday announced that it has completed its previously announced purchase of 15-of-the-17 brands it agreed to acquire from GlaxoSmithKline.

Prestige did not identify the two brand acquisitions not yet completed.

The former GSK brands represent approximately $200 million in annual revenues, which is projected to push Prestige annual revenues above $600 million, Prestige stated in an investor presentation in December.

February 1, 2012

For the past several years, drug industry experts have spoken in terms of the “patent cliff,” the period when the patents covering several blockbuster drugs are set to expire, thus leaving their manufacturers with a big, gaping hole in their revenues as those drugs face competition from generics.

For the past several years, drug industry experts have spoken in terms of the “patent cliff,” the period when the patents covering several blockbuster drugs are set to expire, thus leaving their manufacturers with a big, gaping hole in their revenues as those drugs face competition from generics.

February 1, 2012

A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

NEW YORK — A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

Pfizer announced the voluntary nationwide recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 additional lots of the drug's generic version. Pfizer manufactured and packaged the drugs, while Akrimax Pharmaceuticals commercialized them, and they were sold under the Akrimax brand.

January 31, 2012

The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

The FDA approved Hi-Tech's lorazepam oral concentrate in the 2-mg-per-mL strength, a generic version of Roxanne Labs' Intensol.

Branded and generic versions of the drug had sales of $10 million in 2011, according to IMS Health.


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January 31, 2012

The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

INDIANAPOLIS — The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

The FDA approved Jentadueto (linagliptin and metformin) tablets, designed to be taken twice daily. The approval marks the second since the two companies announced their collaboration to develop diabetes drugs in January 2011; the first drug approved under the Lilly-BI partnership was Tradjenta (linagliptin), approved in May 2011.

January 27, 2012

The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

January 27, 2012

Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

January 26, 2012

Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

THOUSAND OAKS, Calif. — Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

Amgen announced plans to buy Micromet for $1.16 billion, or $11 per share. Micromet, originally founded in Germany, is developing blinatumomab, currently in phase-2 trials as a treatment for acute lymphoblastic leukemia and non-Hodgkin's lymphoma. The acquisition also will include the company's research and development center in Munich.

January 26, 2012

A federal court has stopped an injunction that would have prevented drug maker Watson Pharmaceuticals and partner company Amphastar Pharmaceuticals from marketing or selling a generic version of a blood-thinning drug.

PARSIPPANY, N.J. — A federal court has stopped an injunction that would have prevented drug maker Watson Pharmaceuticals and partner company Amphastar Pharmaceuticals from marketing or selling a generic version of a blood-thinning drug.

January 23, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

January 20, 2012

One issue that is unlikely to see resolution this year is the growing problem of drug shortages. As of October 2011, the Food and Drug Administration and the American Society of Health Systems Pharmacists found shortages of 168 drugs.

One issue that is unlikely to see resolution this year is the growing problem of drug shortages. As of October 2011, the Food and Drug Administration and the American Society of Health Systems Pharmacists found shortages of 168 drugs. According to healthcare analytics firm IMS Health, while this represents a small and highly concentrated portion of the overall drug market, it includes a number of critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system disorders and pain.

January 20, 2012

One analysis report after another seems to confirm that the generic drug market is in for a huge shift as the number of blockbuster drugs losing patent protection is set to dwindle over the next several years. A recent report by Frost & Sullivan seems to confirm that sentiment.

WHAT IT MEANS AND WHY IT'S IMPORTANT — One analysis report after another seems to confirm that the generic drug market is in for a huge shift as the number of blockbuster drugs losing patent protection is set to dwindle over the next several years. A recent report by Frost & Sullivan seems to confirm that sentiment.

January 20, 2012

With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


January 20, 2012

In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.

In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.

January 20, 2012

If the patent cliff were a sports team, Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin) would be its mascot.

If the patent cliff were a sports team, Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin) would be its mascot. Because it’s the top-selling drug, well, ever — with 2010 sales well in excess of $7 billion in the United States alone — Lipitor’s loss of patent protection on Nov. 30, 2011, didn’t start or end the patent cliff but in many ways symbolized it.


January 19, 2012

Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.