Generics

MUMBAI, India The Food and Drug Administration has approved a generic version of a drug for a devastating muscular disorder.

 

Sun Pharmaceutical Industries announced Tuesday the approval of riluzole hydrochloride in the 50-mg strength. The tablets are used to treat amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease.

 

 

The drug is a generic version of Sanofi-Aventis’ Rilutek, which has sales of around $50 million, according to Sun.

 

Many generic drug companies have long marketed branded drugs on the side, but lately, some branded drug companies have sought to enter the generics business as well. One of those companies is Meda Pharmaceuticals, the U.S. subsidiary of Swedish drug maker Meda AB. Drug Store News recently interviewed John White, Meda’s senior director of marketing.

Drug Store News: What gave Meda the idea of pursuing generics?

AMITYVILLE, N.Y. Hi-Tech Pharmacal will market a generic version of a drug used to treat opioid dependence, the company said Monday.

 

Hi-Tech announced that it would market buprenorphine hydrochloride in the 2-mg and 8-mg strengths through its Midlothian Labs division. The drug is in the form of a tablet placed under the tongue.

 

 

The tablets are a generic version of Reckitt Benckiser’s Subutex, which had sales of $75 million during the 12-month period ended in June, according to IMS Health.

 

ALLEGAN, Mich. Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for frequent heartburn, prompting a lawsuit from the branded version’s manufacturer.

The company announced Friday that it had filed for approval for omeprazole and sodium bicarbonate in the 20 mg/1,100 mg strength. The medication is a generic version of Zegerid OTC, made by Schering-Plough HealthCare, a subsidiary of Merck.

 

JERUSALEM Teva filed a complaint against a generic drug maker this week, asserting four patents for its multiple sclerosis drug are being infringed.

PITTSBURGH A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions of an antidepressant drug.

 

Generic drug maker Mylan said Tuesday that it had obtained a temporary restraining order from the U.S. District Court for the District of New Jersey prohibiting Apotex from selling generic versions of the drug Paxil CR (paroxetine hydrochloride), an extended-release formulation of GlaxoSmithKline’s Paxil.

 

 

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.

 

Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.

 

 

WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.

 

The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.

 

 

According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”