Content about Modafinil

July 31, 2013

The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

BALTIMORE — The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

Lupin announced the tentative approvals for armodafinil tablets in the 50-mg, 100-mg, 150-mg, 200-mg and 250-mg strengths and doxycycline capsules in the 40-mg strength. Tentative approval means that the drugs meet the FDA's conditions for approval, but can't be marketed yet due to patent or market exclusivity protection that has yet to expire.

September 18, 2012

Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


NEW YORK — Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


August 10, 2012

Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

The generic drug maker announced the launch of modafinil tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Provigil, made by Cephalon — a company that Teva Pharmaceutical Industries acquired last year — and used to treat narcolepsy, obstructive sleep apnea and shift work disorder.

June 8, 2012

Mylan announced that its subsidiary has resolved all disputes with Teva pertaining to the sale of generic versions of a sleep disorder drug.

PITTSBURGH — Mylan announced that its subsidiary has resolved all disputes with Teva pertaining to the sale of generic versions of a sleep disorder drug.

April 30, 2012

Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

PITTSBURGH — Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

Mylan said it had settled with Teva over the former's generic version of Nuvigil (armodafinil) tablets, a drug used to treat sleepiness related to sleep apnea, narcolepsy and shift work disorder.

April 6, 2012

Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.

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.

March 30, 2012

Teva Pharmaceutical Industries has launched an authorized generic version of Cephalon's Provigil, used for conditions like shift work sleep disorder and narcolepsy, the company said Friday.

JERUSALEM — Teva Pharmaceutical Industries has launched an authorized generic version of Cephalon's Provigil, used for conditions like shift work sleep disorder and narcolepsy, the company said Friday.

Teva acquired Cephalon for $6.8 billion in October 2011. An authorized generic is the branded drug marketed under its generic name at a reduced price.

Provigil had annual sales of about $1.1 billion, according to IMS Health.

 

October 10, 2011

The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

JERUSALEM — The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

Before it can complete the $6.8 billion deal, Teva must sell to Par Pharmaceutical Cos. its generic versions of two Cephalon drugs, namely generic versions of the cancer pain drug Actiq (fentanyl citrate) and the muscle relaxant drug Amrix (cyclobenzaprine), which have combined sales of $298 million per year, according to IMS Health.

March 30, 2011

Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

The buyout offer, equal to $73 per share, includes a 29% premium over Cephalon’s stock price. Valeant noted it had made previous offers, but was “disappointed by Cephalon’s unwillingness to engage in discussions in a timely manner.”

October 24, 2010

The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep...

FRAZER, Pa. The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep disorder drugs made by Cephalon, the drug maker said.

 

Cephalon announced that the FDA approved the REMS for Nuvigil (armodafinil) and Provigil (modafinil), both used to improve wakefulness in patients with sleep apnea, narcolepsy or shift work disorder.

 

 

March 29, 2010

The Federal Trade Commission’s crusade against patent settlements between branded and generic drug makers moved...

March 29, 2010

The Food and Drug Administration declined to approve a Cephalon drug as a treatment for...

January 10, 2010

Drug maker Cephalon and its French subsidiary sued generic drug maker Mylan in connection with...

January 5, 2010

Watson has filed an abbreviated new drug application for the generic version of a sleep...