Content about Generics

March 8, 2011

Generic drug maker Hospira has appointed Mike Ball as CEO, effective March 28, the company said. Ball currently is president of Allergan.

LAKE FOREST, Ill. — Generic drug maker Hospira has appointed Mike Ball as CEO, effective March 28, the company said. Ball currently is president of Allergan.

Ball, who also was appointed to the company’s board, will replace Christopher Begley, who will assume the role of executive chairman.

March 4, 2011

Endo's board of directors has expanded to nine members with the addition of David Nash.

CHADDS FORD, Pa. — Endo's board of directors has expanded to nine members with the addition of David Nash.

Nash, who is the founding dean of the Jefferson School of Population Health at Thomas Jefferson University in Philadelphia, also serves as a board member for Humana.

Endo chairman, Roger Kimmel, said the board welcomes Nash's contributions as Endo continues to diversify its business.

March 4, 2011

Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

SILVER SPRING, Md. — Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

The FDA said Friday that the drug topiramate could increase the risk for such birth defects as cleft palate and cleft lip when used by expectant mothers. Johnson & Johnson markets the drug under the name Topamax, and it is available in generic form.

March 4, 2011

Hospira launched a new online resource that catalogs all of its products available in the United States.

LAKE FOREST, Ill. — Hospira launched a new online resource that catalogs all of its products available in the United States.

Hospira said that the U.S. product catalog, available at Hospira.com/catalog, allows customers, including healthcare facilities and medical care providers, to search Hospira's more than 1,200 products in a variety of ways: alphabetically, by product name, by list number or by therapeutic class.

March 4, 2011

A subsidiary of Endo Pharmaceuticals has won approval from the Food and Drug Administration for an oral contraceptive.

HUNTSVILLE, Ala. — A subsidiary of Endo Pharmaceuticals has won approval from the Food and Drug Administration for an oral contraceptive.

Qualitest Pharmaceuticals announced Friday the approval of Emoquette (desogestrel and ethinyl estradiol) tablets in the 0.15-mg/0.03-mg strength.

The drug is a generic version of Johnson & Johnson’s Ortho-Cept.

March 4, 2011

SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.

March 3, 2011

The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

BRIDGEWATER, N.J. — The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

The FDA approved indomethacin extended-release capsules in the 75-mg strength. The drug is used to treat pain associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, bursitis and tendonitis.

March 3, 2011

In a letter penned Thursday by the National Association of Chain Drug Stores to Sen. Olympia Snowe, R-Maine, the association stated that while it shares the goal of reducing prescription drug costs, authorizing the reimportation of prescription medications — as sought in S.319, the Pharmaceutical Market Access and Drug Safety Act of 2011 — raises concerns about patient health and safety.

ALEXANDRI, Va. — In a letter penned Thursday by the National Association of Chain Drug Stores to Sen. Olympia Snowe, R-Maine, the association stated that while it shares the goal of reducing prescription drug costs, authorizing the reimportation of prescription medications — as sought in S.319, the Pharmaceutical Market Access and Drug Safety Act of 2011 — raises concerns about patient health and safety.

March 3, 2011

Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

PASADENA, Calif. — Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

The study, sponsored by Kaiser Permanente and published online in the Journal of Urology, found that men who took nonsteroidal anti-inflammatory drugs, or NSAIDs, three times a day for more than three months were 2.4 times as likely to have erectile dysfunction as men who didn’t take the drugs regularly. The study used data from 80,966 men ages 45 to 69 years in California.

March 3, 2011

The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

WASHINGTON — The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

The Pharmaceutical Care Management Association announced Thursday that president and CEO Mark Merritt had received the GPhA’s Outstanding Contribution Award at the generic drug industry group’s annual meeting in Orlando, Fla. The organization has advocated increased generic drug utilization and found common cause with the generics industry in its support for follow-on biologics.

March 2, 2011

A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

PITTSBURGH — A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

March 2, 2011

The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.

March 1, 2011

Patients who take generic antidepressants will remain as adherent as those who take brand-name drugs to treat the condition, according to a new study.

ST. LOUIS — Patients who take generic antidepressants will remain as adherent as those who take brand-name drugs to treat the condition, according to a new study.

The study, conducted by Express Scripts and published in the Journal of Managed Care Pharmacy, found patients starting generic selective serotonin reuptake inhibitors and generic selective norepinephrine reuptake inhibitors had a discontinuation rate of 44.2%, compared with 46.8% among those on brand-name SSRIs and SNRIs.

March 1, 2011

Mylan's board of directors now includes the drug maker's president.

PITTSBURGH — Mylan's board of directors now includes the drug maker's president.

Mylan said its board of directors now includes Mylan president Heather Bresch and Robert Cindrich, who currently serves as senior adviser to the office of the president at the University of Pittsburgh Medical Center, a global health enterprise.

With the additions of Bresch and Cindrich, Mylan's board now has 11 members.

March 1, 2011

Teva on Tuesday said that a trial date has been set for its ongoing patent infringement litigation against several drug makers.

JERUSALEM — Teva on Tuesday said that a trial date has been set for its ongoing patent infringement litigation against several drug makers.

Teva said the U.S. District Court for the Southern District of New York will commence proceedings Sept. 7. Teva's litigation is against Momenta Pharmaceuticals/Sandoz and Mylan Pharmaceuticals/Mylan/Natco Pharma regarding their purported generic versions of Copaxone (glatiramer acetate injection).

February 28, 2011

The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

PITTSBURGH — The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

Mylan announced Monday the approval of Matrix Labs’ gabapentin capsules in the 100-mg, 300-mg and 400-mg strengths. The drug is used to treat postherpetic neuralgia, a painful complication of shingles.

Gabapentin capsules had sales of about $300 million in 2010, according to IMS Health.

February 25, 2011

Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

February 24, 2011

Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.

Profits were $17.5 million for the quarter and $92.7 million for the year, compared with $10.7 million in fourth quarter 2009 and $76.9 million for 2009 as a whole.

February 23, 2011

Generic drug maker Caraco Pharmaceutical Industries will merge with Sun Pharmaceutical Industries, Caraco said Tuesday.

DETROIT — Generic drug maker Caraco Pharmaceutical Industries will merge with Sun Pharmaceutical Industries, Caraco said Tuesday.

Sun, which already owns 75.8% of Caraco, will pay $5.25 per share for the remaining shares of Caraco that it doesn’t already own and make Caraco a private company.

Sun originally made the going private offer in December, offering $4.75 per share for Caraco.

February 22, 2011

The Generic Pharmaceutical Association has elected its 2011 executive committee and board of directors, the generic drug industry trade group announced. As part of a reorganization last year, the board has been reduced to 12 members.

ORLANDO, Fla. — The Generic Pharmaceutical Association has elected its 2011 executive committee and board of directors, the generic drug industry trade group announced. As part of a reorganization last year, the board has been reduced to 12 members.

The GPhA said Watson Pharmaceuticals president and CEO Paul Bisaro had been reelected as chairman for a second, one-year term. Also elected were Mylan Pharmaceuticals president Tony Mauro, as vice chairman; and Momenta Pharmaceuticals president Craig Wheeler, as secretary treasurer.

February 22, 2011

Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

Hi-Tech announced the approval of gabapentin oral solution in the 250 mg/5 mL strength, a generic version of Pfizer’s Neurontin oral solution.

The drug is used to treat postherpetic neuralgia and epilepsy. Neurontin had sales of $15 million in 2010, according to IMS Health.

February 22, 2011

Sales at Medco Health Solutions increased to $16.9 billion during fourth quarter 2010 and to $66 billion for the fiscal year as a whole, representing respective 11.1% and 10.3% increases over the same periods the year before, the pharmacy benefit manager said Tuesday.

FRANKLIN LAKES, N.J. — Sales at Medco Health Solutions increased to $16.9 billion during fourth quarter 2010 and to $66 billion for the fiscal year as a whole, representing respective 11.1% and 10.3% increases over the same periods the year before, the pharmacy benefit manager said Tuesday.

Profits for the quarter were $378.5 million, a 10.8% increase over fourth quarter 2009, while profits for the year were $1.4 billion, an 11.5% increase over fiscal year 2009.

February 22, 2011

Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

ALLEGAN, Mich. — Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

Perrigo announced Tuesday that it had filed an application with the FDA for calcipotriene and betamethasone dipropionate in the 0.005%/0.064% strength. The drug is a generic version of Leo Pharma’s Taclonex and is used to treat psoriasis vulgaris in adults.

February 22, 2011

Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

February 18, 2011

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.