Content about Clinical research

December 10, 2012
FDA grants Astellas NDA for tacrolimus extended-release capsules

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

December 7, 2012
Mylan launches generic hypertension drug

The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

PITTSBURGH — The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

Mylan announced the approval and launch of candesartan cilexetil and hydrochlorothiazide tablets in the 16/12.5-mg, 32/12.5-mg and 32/25-mg strengths. Mylan said it was the first company to submit a complete regulatory approval application for the drug and is thus entitled to 180 days of market exclusivity in which to compete directly with the branded version.

December 4, 2012
FDA accepts application for GERD drug in children

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

Eisai said the FDA accepted its application for AcipHex delayed-release sprinkle capsules in the 5-mg and 10-mg strengths for healing of gastroesophageal reflux disease, and maintenance of healing of GERD and improvement of symptoms in children ages 1 year to 11 years.

The FDA expects to have the application reviewed by March 27, 2013. The drug is currently approved in the 20-mg strength for adolescents and adults.

November 30, 2012
FDA approves new medullary thyroid cancer drug

The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

The FDA announced the approval of Cometriq (cabozatinib) to treat medullary thyroid cancer — a cancer that develops in cells in the thyroid gland that make calcitonin, a hormone that helps maintain a healthy level of calcium in the blood — that has spread to other parts of the body. Another drug to treat medullary thyroid cancer, AstraZeneca's Caprelsa (vandetanib), was approved last year.

November 29, 2012
FDA approves Mylan overactive bladder drug

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.

Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.

November 29, 2012
FDA panel backs J&J tuberculosis drug

A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.

RARITAN, N.J. — A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.

November 29, 2012
Industry divided over patent settlements

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


November 29, 2012
User fee re-authorization 
fuels generics’ outlook

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


November 28, 2012
Durbin, Blumenthal ask FDA to review energy drinks quickly

Some legislators are concerned with the way energy drinks can affect young consumers.

Some legislators are concerned with the way energy drinks can affect young consumers, especially in light of news reports linking several deaths with energy drink use.

Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., are urging the Food and Drug Administration to move quickly to review the safety of these drinks.

November 28, 2012
FDA approves Perrigo, Cobrek scalp psoriasis treatment

The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

Perrigo said that Cobrek, with which it is partnering, had received approval for betamethasone validate foam in the 0.12% strength. The drug is a generic version of Luxiq foam, made by GlaxoSmithKline subsidiary Stiefel Labs, and is used to treat corticosteroid-responsive skin conditions of the scalp, also known as scalp psoriasis.

The branded version of the drug has annual sales of about $40 million, according to Perrigo.

November 27, 2012
Wockhardt receives three FDA approvals

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

SILVER SPRING, Md. — Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

November 19, 2012
FDA approves GSK drug for hepatitis C patients with low platelet counts

The Food and Drug Administration has approved a drug for a condition that can complicate treatment for hepatitis C.

LONDON — The Food and Drug Administration has approved a drug for a condition that can complicate treatment for hepatitis C.

GlaxoSmithKline said Monday that the FDA had approved Promacta (eltrombopag) for treating low blood-platelet counts, also known as thrombocytopenia, to allow patients with hepatitis C to undergo and maintain interferon-based therapy. The drug already had FDA approval to treat chronic immune thrombocytopenia. 

November 15, 2012
Generic drugs compete in game of differentiation

The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


November 15, 2012
Generics target specialty pharmacy with biosimilars

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


November 15, 2012
NewsBytes — Chain Pharmacy, 11/19/12

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.


The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.



 

November 14, 2012
FDA wants more oversight of compounding pharmacies

Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a national meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

NEW YORK — Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a nationwide meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

November 13, 2012
Reports: AMA supports legislation against 'pay-for-delay' deals

The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

NEW YORK — The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

Forbes reported that the AMA would support federal legislation to ban so-called "pay-for-delay" settlements. The AMA joins the Federal Trade Commission, which has strongly criticized the settlements

November 12, 2012
FDA approves new strength of HIV drug

The Food and Drug Administration has approved a new strength of a drug for HIV made by Johnson & Johnson, the drug maker said.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a new strength of a drug for HIV made by Johnson & Johnson, the drug maker said.

J&J subsidiary Janssen Therapeutics announced the approval of an 800-mg formulation of Prezista (darunavir) as a once-daily treatment for HIV. The drug is designed to be taken with food at the same time as ritonavir and in combination with other HIV drugs.

November 8, 2012
FDA accepts Merck application for insomnia drug

The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

Merck announced the the FDA's acceptance of its regulatory filing for suvorexant, which the FDA's Controlled Substances Staff will review while the agency is reviewing the application.

November 7, 2012
FDA issues warning letter to company making illegal claims in support of light therapy device

The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease and other diseases.

SILVER SPRING, Md. — The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease and other diseases.

November 5, 2012
FDA approves J&J anti-clotting drug

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

J&J subsidiary Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) for treating deep-vein thrombosis and pulmonary embolism and to reduce the risk of recurrence of the clotting conditions after initial treatment.

The company said Xarelto was the first oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood-monitoring.

November 5, 2012
NewsBytes — Chain Pharmacy, 11/5/12

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

FDA approves cardiovascular drug

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain. Actavis announced the approval of diltiazem hydrochloride extended-release capsules.
The drug is a generic version of Valeant’s Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.



November 1, 2012
Reports: Generic extended-release drugs to get more attention from FDA

Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

October 31, 2012
Sandoz starts phase-3 trial of biosimilar anemia drug

Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

HOLZKIRCHEN, Germany — Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started enrolling patients for a phase-3 study of epoetin alfa, a biosimilar version of Epogen and Procrit, made by Amgen and Johnson & Johnson and used to treat anemia associated with chronic kidney disease.

October 29, 2012
Watson launches generic version of Actos

The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

PARSIPPANY, N.J. – The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

Watson announced the launch of 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 ended in August, according to IMS Health.