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June 22, 2011

ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.

GALASHIELS, Scotland, and BEDMINSTER, N.J. — ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.

The drug maker, which is a subsidiary of Kyowa Hakko Kirin, said that it received regulatory approval for Rectiv (nitroglycerin) ointment 0.4%. Rectiv currently is the only FDA-approved prescription product for patients with this condition. ProStrakan expects Rectiv to be available in the United States in first quarter 2012.

June 21, 2011

The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

SILVER SPRING, Md. — The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

June 20, 2011

Last month, the Food and Drug Administration approved Tradjenta (linagliptin), an oral Type 2 diabetes drug made by German drug maker Boehringer Ingelheim and Indianapolis-based Eli Lilly. The drug belongs to the class known as dipeptidyl peptidase-4 inhibitors, which also includes Merck’s Januvia (sitagliptin). With diabetes affecting some 26 million Americans and growing rapidly, Drug Store News spoke with Wa’el Hashad, BI’s VP cardiovascular and metabolic disorders marketing, about what the approval of Tradjenta means for the diabetes market.


June 16, 2011

Unilever's offer to shed some of its bar soap business to win United Kingdom competition approval for its acquisition of hair and personal care products manufacturer Alberto Culver was accepted by the U.K. Office of Fair Trading.

LONDON — Unilever's offer to shed some of its bar soap business to win United Kingdom competition approval for its acquisition of hair and personal care products manufacturer Alberto Culver was accepted by the U.K. Office of Fair Trading.

"Following a consultation, and having carefully assessed the financial position and commitment of the purchaser, Lornamead, we are satisfied that this divestment will ensure there continues to be effective competition in this market," said Ali Nikpay, OFT senior director for U.K. Office of Fair Trading.

June 8, 2011

The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

June 7, 2011

Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

HYDERABAD, India — Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

The drug maker said that the FDA approved donepezil hydrochloride tablets, a generic version of Pfizer and Eisai's Arciept, in the 5-mg and 10-mg strengths for the treatment of Alzheimer's disease. Both strengths will be available in 30-, 90- and 500-count bottles.

May 23, 2011

The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.

Mylan said Monday that the FDA had approved its divalproex sodium capsules in the 125-mg strength. The drug is a generic version of Abbott’s Depakote Sprinkle capsules and is used to treat certain types of epileptic seizures.

Divalproex sodium capsules had sales of about $89 million during the 12-month period ended in March, according to IMS Health.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

HAYWARD, Calif. — The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

Impax Pharmaceuticals, as the division is known, said it filed an investigational new drug application with the Food and Drug Administration for IPX159 and started a phase-1 study.

April 26, 2011

The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

April 25, 2011

Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.

REDWOOD CITY, Calif. — Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.

AP announced the appointment of John Whelan as president, CEO and director, and Michael Adam as SVP and COO.

April 25, 2011

SUPPLIER NEWS — Hi-Tech Pharmacal announced the tentative approval by the Food and Drug Administration of levofloxacin oral solution in the 25-mg/mL strength, a generic antibiotic. Levofloxacin oral solution is a generic version of Johnson & Johnson’s Levaquin, which had sales of $6 million in 2010, according to IMS Health. Hi-Tech expected to receive final approval in June, when Johnson & Johnson’s patent expires.


April 21, 2011

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.

April 11, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

J&J said Monday that the FDA had approved Invega (paliperidone) extended-release tablets for patients ages 12 to 17 years. The drug is marketed by J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals. The drug originally was approved in 2006 for treating schizophrenia in adults.

April 5, 2011

The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

RIDGEFIELD, Conn. — The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

The FDA approved Viramune XR (nevirapine), a single-pill, once-daily, extended-release formulation of nevirapine for use in combination with other antiretroviral drugs.

March 28, 2011

The Food and Drug Administration has approved a topical treatment for genital warts made by Graceway Pharmaceuticals, the drug maker said Monday.

BRISTOL, Tenn. — The Food and Drug Administration has approved a topical treatment for genital warts made by Graceway Pharmaceuticals, the drug maker said Monday.

The FDA approved Zyclara (imiquimod) cream in the 3.75% strength for patients ages 12 years and older. According to clinical trial data, the cream effectively cleared genital warts, and of patients who achieved complete clearance, only a small percentage had a recurrence 12 weeks after treatment.

March 24, 2011

The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

BASEL, Switzerland — The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

March 4, 2011

The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

The FDA approved Banzel (rufinamide) oral suspension for the treatment of seizures in children and adults with Lennox-Gastaut syndrome. The condition, also called LGS, affects 1% to 4% of children with epilepsy.

“This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” Eisai president and CEO Lonnel Coats said.

March 3, 2011

The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

DARMSTADT, Germany — The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

February 18, 2011

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 8, 2011

Valeant Pharmaceuticals subsidiary Biovail Labs International has licensed Canadian rights to a treatment for acne from Allergan, Valeant said Tuesday.

MISSISSAUGA, Ontario — Valeant Pharmaceuticals subsidiary Biovail Labs International has licensed Canadian rights to a treatment for acne from Allergan, Valeant said Tuesday.

Under the terms of the agreement concerning the drug Aczone (dapsone) gel in the 5% strength, Biovail will pay Allergan about $500,000 Canadian dollars (about $504,693) upfront, as well as payments based on net sales.

February 1, 2011

The Food and Drug Administration has approved a Novartis vaccine for preventing meningococcal disease in children, the Swiss drug maker said.

BASEL, Switzerland — The Food and Drug Administration has approved a Novartis vaccine for preventing meningococcal disease in children, the Swiss drug maker said.

Novartis announced the approval of Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for active immunization to prevent certain forms of meningococcal disease caused by Neisseria meningitidis in children ages 2 to 10 years. The FDA approved the vaccine last year for use in adolescents and adults ages 11 to 55 years.

January 31, 2011

Anticipating regulatory approval, MAP Pharmaceuticals and Allergan will collaborate to promote a drug for treating acute migraine to physicians.

IRVINE, Calif. — Anticipating regulatory approval, MAP Pharmaceuticals and Allergan will collaborate to promote a drug for treating acute migraine to physicians.

The two companies announced the collaboration Monday for Levadex (dihydroergotamine), an inhaled drug. Phase-3 trials for the drug are finished, and MAP plans to submit an approval application for the drug to the Food and Drug Administration in the first half of this year.

January 27, 2011

A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

January 24, 2011

An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

MOUNTAIN VIEW, Calif. — An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

Alexza Pharmaceuticals announced results of a phase-3 trial of the inhaled drug AZ-004 (loxapine), which showed statistically significant improvement in symptoms of agitation in patients compared with the placebo.