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May 3, 2013

Actavis sales up 24% in first quarter 2013

Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

PARSIPPANY, N.J. — Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

The latest figure represented a 24% increase from first quarter 2012's $1.52 billion. "The new Actavis is off to a strong start in 2013, and as a result, we are increasing our 2013 forecast based on the strong performance and execution against our objectives to date," president and CEO Paul Bisaro said.

April 5, 2013

Actavis to market, distribute authorized generic version of Valeant drug; Valeant to co-promote Actavis drug

Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

PARSIPPANY, N.J. — Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

The agreement centers around Zovirax, known generically as acyclovir, in the 5% strength. The Food and Drug Administration approved the generic version, made by Mylan, on Wednesday. Financial terms of the deal were not disclosed.

April 4, 2013

Valeant earnings per share could take hit in 2013 from herpes ointment generic

The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

MONTREAL — The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

Canada-based Valeant Pharmaceuticals International said that while it expected Mylan to receive approval for a generic version of Zovirax (acyclovir) ointment, it did not include the approval in its original budget expectations and thus expected its earnings per share in fiscal year 2013 to be reduced by 30 to 40 cents.

April 3, 2013

FDA approves Mylan genital herpes ointment

The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said.

PITTSBURGH — The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said Wednesday.

Mylan announced the approval of acyclovir ointment in the 5% strength. The drug is a generic version of Valeant International's Zovirax, used to manage initial genital herpes and in limited, non-life-threatening mucocutaneous herpes simplex virus infections in patients with compromised immune systems.

December 18, 2012

FDA approves generic HIV drug

The Food and Drug Administration has approved two generic versions of a drug to treat HIV, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved two generic versions of a drug to treat HIV, according to agency records.

The FDA approved abacavir sulfate tablets in the 300-mg strength made by Apotex and Aurobindo.

The drug is a generic version of Viiv Healthcare's Ziagen.

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March 1, 2011

Cold sore treatment Xerese enters market

Meda has launched a new cold sore treatment made by commercialization partner Medivir, Medivir said Tuesday.

HUDDINGE, Sweden — Meda has launched a new cold sore treatment made by commercialization partner Medivir, Medivir said Tuesday.

The Swedish drug maker launched Xerese (acyclovir and hydrocortisone), a topical combination product designed to treat recurrent herpes simplex labialis.

Medivir said the U.S. market for cold sore products is $230 million, and it expected the drug to be successful, given Meda’s presence in the U.S. market.

February 3, 2011

Valeant receives U.S., Canadian rights for Zovirax

Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores.

MISSISSAUGA, Ontario — 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 announced Thursday that it had acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.

December 7, 2010

Under PEPFAR, Matrix gets tentative approval for Ziagen generic

The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.

The tentative approval under PEPFAR covers Matrix’s abacavir sulfate tablets in the 60-mg strength. The drug is a generic version of ViiV Healthcare’s Ziagen, and is used to treat the disease in children.

September 14, 2010

FDA issues new dosing guide for children using Valcyte

The Food and Drug Administration has approved new dosing recommendations for children and adolescents using...

WASHINGTON The Food and Drug Administration has approved new dosing recommendations for children and adolescents using a drug for heart and kidney transplants.

The agency announced Wednesday the recommendations, designed to prevent overdosing in children taking Genentech’s antiviral Valcyte (valganciclovir), particularly among those of low weight, smaller size and very low serum creatinine.

January 31, 2010

FDA issues safety risk for HIV drug

A rare but serious liver disorder has been reported in some patients taking a drug...