Content about Abbreviated New Drug Application

December 11, 2012

The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

NEW YORK — The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

Politico reported that the justices had agreed to hear three cases, including Federal Trade Commission v. Watson Pharmaceuticals, involving settlements between branded and generic drug companies that critics deride as "pay-for-delay" deals.

November 29, 2012

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


November 15, 2012

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


October 29, 2012

Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

WOODCLIFF LAKE, N.J. – Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

August 2, 2012

Big Doctor is watching you — to make sure you're taking your drugs as prescribed, that is.

REDWOOD CITY, Calif. — Big Doctor is watching you — to make sure you're taking your drugs as prescribed, that is.

It's not dystopian, but it sure sounds like the stuff of science fiction: The Food and Drug Administration approved Monday a tiny, ingestible sensor that can be integrated into drugs to monitor patients' prescription drug adherence.

July 16, 2012

Is the reauthorization of the Prescription Drug User Fee Act “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act?”

Is the reauthorization of the Prescription Drug User Fee Act “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act?”

The generic drug industry’s chief spokesman and top lobbyist says so, at any rate. Ralph Neas, president and CEO of the Generic Pharmaceutical Association, called the newly enacted Food and Drug Administration Safety and Innovation Act “a remarkable achievement for patients, industry and the FDA.”

July 10, 2012

President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

WASHINGTON — President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

July 5, 2012

The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

May 18, 2012

Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength.

ALLEGAN, Mich. — Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength. The capsules are a generic equivalent of Novartis' Prevacid 24HR capsules.

Sales for Prevacid OTC were approximately $220 million, Perrigo reported.


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April 23, 2012

Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

Handa, based in Fremont, Calif., sold rights to the regulatory approval application it filed with the Food and Drug Administration for dexlansoprazole capsules, a generic version of Takeda's Dexilant, in the 60-mg strength.

March 14, 2012

Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

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.

January 23, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

January 20, 2012

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


December 12, 2011

Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

WASHINGTON — Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

November 4, 2011

In the classic “Arabian Nights” tale of Aladdin and his magic lamp, the evil sorcerer who made Aladdin retrieve the lamp containing the genie attempts to get it back by tricking Aladdin’s wife into giving it to him by roaming through the streets offering to trade “new lamps for old.”


In the classic “Arabian Nights” tale of Aladdin and his magic lamp, the evil sorcerer who made Aladdin retrieve the lamp containing the genie attempts to get it back by tricking Aladdin’s wife into giving it to him by roaming through the streets offering to trade “new lamps for old.”


September 13, 2011

Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

August 12, 2011

Watson Pharmaceuticals will build a drug warehouse and distribution center in Mississippi, the drug maker said Thursday.

PARSIPPANY, N.J. — Watson Pharmaceuticals will build a drug warehouse and distribution center in Mississippi, the drug maker said Thursday.

Watson said its Anda Distribution division would the $23.5 million, 234,000-sq.-ft. center in Olive Branch, Miss. The plant will employ 70 workers.

July 25, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said. Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.


June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

May 17, 2011

Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

ALLEGAN, Mich. — Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

Zantac 150 has annual sales of approximately $110 million, as measured by SymphonyIRI Group, Perrigo reported.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

February 22, 2011

Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

February 18, 2011

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.

Impax said its generic division, Global Pharmaceuticals, will launch the product.

February 17, 2011

The Food and Drug Administration has seized supplies of a drug used to treat ear infections, under a program the agency started to remove unapproved drugs from the market.

SILVER SPRING, Md. — The Food and Drug Administration has seized supplies of a drug used to treat ear infections, under a program the agency started to remove unapproved drugs from the market.

The FDA announced the seizure of about $16.5 million worth of Auralgan otic solution made by Brooks, Ky.-based Integrated Commercialization Solutions. Chapel Hill, N.C.-based Deston Therapeutics manufactures the drug, while ICS warehouses it.