Content about Mylan

April 5, 2012

Teva is the first company to file for a generic version of a drug to treat sleep disorders, the Food and Drug Administration has determined.

JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.

April 3, 2012

Mylan has released a generic version of a drug used to treat a complication of certain chemotherapy regimens, the drug maker said Tuesday.

PITTSBURGH — Mylan has released a generic version of a drug used to treat a complication of certain chemotherapy regimens, the drug maker said Tuesday.

The company announced the launch of mesna injection in the 100-mg/mL and 1,000-mg/10-mL strengths. The drug is used to reduce the incidence of ifosfamide-induced hemorrhagic cystitis, a possible complication of ifosfamide chemotherapy.

March 28, 2012

Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

NEW YORK — Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

Dr. Reddy's Labs, Teva and Mylan announced Wednesday the launch of their respective versions of quetiapine fumarate tablets, generic formulations of AstraZeneca's Seroquel, in strengths ranging from 25 mg to 400 mg.

March 12, 2012

Mylan is getting new headquarters, the company said.

PITTSBURGH — Mylan is getting new headquarters, the company said.

The generic drug maker said it would build a new headquarters near its current one in Southpointe Office Park in Cecil Township, Pa., south of Pittsburgh.

February 29, 2012

Mylan has launched a generic drug for treating depression and anxiety, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic drug for treating depression and anxiety, the company said Wednesday.

Mylan announced the launch of escitalopram tablets in the 5-mg, 10-mg and 20-mg strengths, the first generic version of Forest Labs' Lexapro. The drug is used for treating major depressive disorder and generalized anxiety disorder.

February 23, 2012

The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

Mylan said Thursday that the FDA had tentatively approved Mylan Labs' abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare's Epzicom and was approved under the President's Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.

February 23, 2012

The president of one of the world's largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.

WASHINGTON — The president of one of the world's largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.

February 21, 2012

Mylan on Friday announced that the company and its subsidiary, Mylan Pharmaceuticals, have resolved the defamation and other related litigation filed by Mylan against the Pittsburgh Post-Gazette and two of its reporters.

PITTSBURGH — Mylan on Friday announced that the company and its subsidiary, Mylan Pharmaceuticals, have resolved the defamation and other related litigation filed by Mylan against the Pittsburgh Post-Gazette and two of its reporters.

"The litigation has been resolved to the satisfaction of both parties," the parties said in a joint statement. "The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise."

February 15, 2012

Mylan is changing the name of its branded specialty pharmaceutical business, the company said Wednesday.

PITTSBURGH — Mylan is changing the name of its branded specialty pharmaceutical business, the company said Wednesday.

The drug maker announced that it would change the name of Dey Pharma to Mylan Specialty. Dey makes treatments for respiratory diseases, psychiatric disorders and severe allergic reactions, including the EpiPen (epinephrine).

February 14, 2012

Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

February 9, 2012

The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan's doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott's Doryx.

February 9, 2012

The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

WASHINGTON — The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

February 6, 2012

Mylan has completed its acquisition of two skin drugs from Valeant Pharmaceuticals, the generic drug maker said Monday.

PITTSBURGH — Mylan has completed its acquisition of two skin drugs from Valeant Pharmaceuticals, the generic drug maker said Monday.

Mylan announced that it had acquired the regulatory approval applications for generic clindamycin phosphate and benzoyl peroxide gel, a generic version of Valeant's BenzaClin, and a license to manufacture and market fluorouracil cream in the 5% strength, a version of Valeant's Efudex.

February 2, 2012

The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

Mylan announced that it had received tentative approval for a generic version of Pfizer's Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.

January 9, 2012

Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

PITTSBURGH — Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

Mylan said that it was sued by Takeda Pharmaceutical, Watson Pharmaceuticals and Andrx Labs in the U.S. District Court for the Southern District of New York in response to Mylan's filing a regulatory approval application with the Food and Drug Administration for a generic version of Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) extended-release tablets in the 15-mg/1,000-mg and 30-mg/1,000-mg strengths.

January 3, 2012

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

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

The FDA approved Mylan's levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.

Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.

January 3, 2012

Mylan has launched a generic drug for treating high blood pressure, the company said.

PITTSBURGH — Mylan has launched a generic drug for treating high blood pressure, the company said.

The drug maker announced the launch of eprosartan mesylate tablets in the 400-mg and 600-mg strengths. The drug is a generic version of Abbott's Teveten and is used to treat hypertension.

December 20, 2011

The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

PITTSBURGH — The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

December 19, 2011

The Food and Drug Administration has approved a drug for treating high blood pressure made by Mylan, FDA records showed.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for treating high blood pressure made by Mylan, FDA records showed.

The FDA approved Mylan's metoprolol succinate tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths.

The drug is a generic version of AstraZeneca's Toprol-XL.

December 5, 2011

Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), a drug for treating symptoms of menopause, Mylan said it had received a patent license to begin selling its version of the drug in December 2013.


SUPPLIER NEWS — Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), a drug for treating symptoms of menopause, Mylan said it had received a patent license to begin selling its version of the drug in December 2013.


The Pittsburgh-based generic drug maker was the first to file for regulatory approval of the drug with the Food and Drug Administration, and as such will be entitled to 180 days of 
market exclusivity.


December 2, 2011

Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

PITTSBURGH — Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

The drug maker's Mylan Labs subsidiary received tentative approval for atazanavir sulfate and ritonavir tablets in the 300-mg/100-mg strength. The FDA's tentative approval of the drug under PEPFAR means it will be eligible for purchase in certain developing countries.

December 1, 2011

Mylan said its subsidiary has launched a generic version of a hypertension treatment.

PITTSBURGH — Mylan said its subsidiary has launched a generic version of a hypertension treatment.

The company said Mylan Pharmaceuticals launched and begun shipping amlodipine besylate and atorvastatin calcium tablets in the 2.5-mg/10-mg; 2.5-mg/20-mg; 2.5-mg/40-mg; 5-mg/10-mg; 5-mg/20-mg; 5-mg/40-mg; 5-mg/80-mg; 10-mg/10-mg; 10-mg/20-mg; 10-mg/40-mg and 10-mg/80-mg strengths. The drug is a generic version of Pfizer's Caduet.

Caduet tablets had U.S. sales of approximately $339 million for the 12 months ended Sept. 30, according to IMS Health.

December 1, 2011

Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.

PITTSBURGH — Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.

Mylan said Thursday that it and Famy Care had been sued by Warner Chilcott in the U.S. District Court for the District of New Jersey following their filing of a regulatory approval application with the Food and Drug Administration for norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets, a generic version of Warner Chilcott's Generess Fe.

November 28, 2011

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

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

Mylan announced Monday the approval of dexrazoxane for injection, a generic version of Pharmacia & Upjohn's Zinecard. The drug is a chemoprotective agent, used to protect healthy tissue from cancer drugs.

Various versions of the drug had sales of $3.4 million during the 12-month period ended in September, according to IMS Health.

 

 

November 21, 2011

Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.