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March 21, 2013

The Food and Drug Administration advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients.

BETHESDA, Md. — The Food and Drug Administration on Thursday advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients. 

March 21, 2013

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

March 21, 2013

Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.

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 19, 2013

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

March 19, 2013

The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.

WASHINGTON — The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients. Those two guidelines will help the agency use adverse event reports in overseeing dietary supplement products, the GAO stated.

March 19, 2013

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

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 14, 2013

The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval and shipment of fluvoxamine maleate extended-release capsules in the 100-mg and 150-mg strengths. The drug is a generic version of Jazz Pharmaceuticals' Luvox CR.

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

The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

March 14, 2013

SoloHealth on Thursday announced it has been selected as one of the Technology Association of Georgia’s Top 10 Innovative Technology Companies. SoloHealth was recognized for its FDA-approved health and wellness kiosk, the SoloHealth Station.

ATLANTA — SoloHealth on Thursday announced it has been selected as one of the Technology Association of Georgia’s Top 10 Innovative Technology Companies. SoloHealth was recognized for its FDA-approved health and wellness kiosk, the SoloHealth Station.

"The Top 10 awards are given to an elite group of companies whose products and solutions are not only changing their respective industries, they also are putting Georgia on the map as a state where technology innovation can thrive," stated Tino Mantella, president & CEO of TAG. 

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 11, 2013

Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

WASHINGTON — Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

March 8, 2013

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

March 5, 2013

Generic drug maker Dr. Reddy's Labs has launched a drug used to treat certain cancers, the company said Tuesday.

HYDERABAD, India — Generic drug maker Dr. Reddy's Labs has launched a drug used to treat certain cancers, the company said Tuesday.

Dr. Reddy's announced the launch of injectable zoledronic acid in the 4-mg-per-5-mL strength. The launch followed the Food and Drug Administration's approval of the drug.

The drug is a generic version of Novartis' Zometa. The drug is used to treat cancers that have spread to the bones and multiple myeloma.

CORRECTION: An earlier version of this story misstated the strength of the drug. The story has been corrected.

March 5, 2013

The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

NEW YORK — The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

The case, FTC v. Actavis, will go before the high court on March 25 and may decide the future of patent settlements between branded and generic drug companies. The Generic Pharmaceutical Association filed an amicus brief with the court last week defending the settlements as beneficial to consumers.

March 4, 2013

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

PHILADELPHIA — The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said Monday.

Iroko is seeking approval for a lower-dose, submicron diclofenac, a non-steroidal anti-inflammatory drug for treating mild to moderate acute pain in adults.

March 4, 2013

The Food and Drug Administration will inspect about 30 compounding pharmacies that it has deemed "high risk," according to published reports.

NEW YORK — The Food and Drug Administration will inspect about 30 compounding pharmacies that it has deemed "high risk," according to published reports.

Businessweek reported that the FDA started visits to the pharmacies started last month and would continue for the next two months. So far, unsanitary conditions were found at pharmacies in Chicago, Florida, Arkansas and Mississippi.

March 1, 2013

The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

WASHINGTON — The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

The high court will hear arguments in the case, Federal Trade Commission v. Actavis, on March 25. The case was originally titled FTC v. Watson, but has changed since Watson Pharmaceuticals changed its name following its acquisition of Swiss generic drug maker Actavis.

February 28, 2013

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago.

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.

February 26, 2013

The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

The agency announced the approval of Shionogi's Osphena (ospemifene) for women with moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause associated with declining levels of estrogen hormones.

February 26, 2013

Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

NEW YORK — Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

The Indian drug maker said it had initiated corrective and preventive actions, or CAPA, as it prepared to resume supplies of generic atorvastatin calcium tablets to the U.S. market. The drug is a generic version of Pfizer's Lipitor, and Ranbaxy became the first company to market a generic version in November 2011.

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 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.