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March 26, 2013

The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

 

March 26, 2013

The National Community Pharmacists Association called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.

ALEXANDRIA, Va. — The National Community Pharmacists Association last week called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.

March 25, 2013

Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug's market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

March 20, 2013

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

March 18, 2013

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

PITTSBURGH — The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

March 18, 2013

Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

LAKE OSWEGO, Ore. — Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

Galena, which specializes in cancer-related drugs, said it acquired Abstral (fentanyl) sublingual tablets for sale and distribution in the United States from Orexo AB. Breakthrough cancer pain, or BTcP, affects between 40% to 80% of cancer patients, with reported episodes of four per day and a median duration of 30 minutes, according to Galena.

March 14, 2013

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

March 14, 2013

Wegmans will be offering the popular cholesterol-lowering drug atorvastatin free of charge through the end of the year, according to a report published by the Philadelphia Inquirer.

PHILADELPHIA — Wegmans will be offering the popular cholesterol-lowering drug atorvastatin free of charge through the end of the year, according to a report published by the Philadelphia Inquirer Wednesday. 

March 13, 2013

Target is expanding its retail clinic presence in the Chicago area, according to published reports.

NEW YORK — Target is expanding its retail clinic presence in the Chicago area, according to published reports.

The Chicago Tribune reported Wednesday that the mass merchandise retailer would open three clinics — two in the suburbs and one in the city. Construction is scheduled to start on May 28, and grand openings are planned for Aug. 18. The Target on Division Street, scheduled to open in October, will also have a clinic.

March 12, 2013

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

March 5, 2013

Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

The generic drug maker announced the shipment of buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The Food and Drug Administration approved the drug in February.

The drug includes a risk evaluation and mitigation strategy, or REMS, a program required by the FDA to ensure that its benefits outweigh its risks.

March 1, 2013

The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

TOKYO — The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

Otsuka Pharmaceutical and H. Lundbeck announced the FDA approval of Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation indicated for the treatment of schizophrenia.

The companies described Abilify Maintena as the first dopamine D2 partial agonist approved as a once-monthly injection, contributing to a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia.

February 26, 2013

Greenstone has launched an authorized generic version of a drug used to treat cholesterol.

PEAPACK, N.J. — Greenstone has launched an authorized generic version of a drug used to treat cholesterol.

Greenstone, the generics arm of Pfizer, announced the launch of authorized generic atorvastatin calcium tablets in the 10 mg, 20 mg, 40 mg and 80 mg strengths, in bottle sizes ranging from 90 to 1,000. The drug is a version of the parent company's cholesterol drug Lipitor.

An authorized generic is a brand marketed under its generic name at a reduced price.

February 25, 2013

Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

 

February 25, 2013

The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

The FDA announced the approval of Stivarga (regorafenib) for gastrointestinal stromal tumors that could not be removed through surgery or had spread to other parts of the body and were no longer responding to treatment with Novartis' Gleevec (imatinib) or Pfizer's Sutent (sunitinib).

February 25, 2013

Mylan has begun shipping a generic drug for cholesterol, the company said Monday.

PITTSBURGH — Mylan has begun shipping a generic drug for cholesterol, the company said Monday.

Mylan said a subsidiary had started shipping fenofibrate capsules in the 43-mg and 130-mg strengths. The drug is a generic version of Lupin Atlantis Holdings Antara, used in combination with diet to reduce elevated bad cholesterol and other blood lipids and increase beneficial HDL cholesterol in patients with primary hypercholesterolemia or mixed dyslipidemia.

February 22, 2013

The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said Friday.

The FDA announced the approval of Genentech's Kadcyla (ado-trastuzumab emtansine) for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein involved in the growth of normal cells but found in increased amounts in some kinds of cancer cells, which contributes to cancer cell growth and survival. Genentech is the U.S. subsidiary of Swiss drug maker Roche.

February 19, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.

February 19, 2013

Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter, the company said.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter in some vials, the company said.

Gilead announced the voluntary recall of lot B120217A of Vistide (cidofovir), an injected drug used to treat cytomegalovirus retinitis in patients with AIDS, due to particulate matter.

February 14, 2013

Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

PARSIPPANY, N.J. — Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

The companies settled patent lawsuit regarding Actavis' generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32-mg strength. The companies settled litigation regarding the 8-mg, 12-mg and 16-mg strengths last month.

February 14, 2013

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

February 8, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

SILVER SPRING, Md. - The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods' pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.

February 7, 2013

An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

STAMFORD, Conn. — An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

The placebo-controlled study, published in the journal Sleep, tested the drug Intermezzo (zolpidem tartrate) sublingual tablets on 295 adults with primary insomnia and difficulty returning to sleep after waking up in the middle of the night. Purdue said Intermezzo was the only drug approved by the Food and Drug Administration for treating such patients.

February 5, 2013

The National Community Pharmacists Association submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Monday submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.

February 4, 2013

Drug maker Perrigo has launched a generic drug for treating problems of the scalp, the company said.

ALLEGAN, Mich. — Drug maker Perrigo has launched a generic drug for treating problems of the scalp, the company said.

Perrigo announced the launch of clobetasol emulsion propionate foam in the 0.05% strength, a generic version of GlaxoSmithKline's Olux-E. The drug is used to treat moderate to severe dermatosis of the scalp.