Content about Abbreviated New Drug Application

April 15, 2014

Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).

DUBLIN — Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).

Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess FE under its pending abbreviated new drug application beginning on April 1, 2015.

April 4, 2014

The National Association of Boards of Pharmacy recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.

MOUNT PROSPECT, Ill. — The National Association of Boards of Pharmacy on Wednesday recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.  

NABP also advises that pharmacists consult with prescribers to discuss alternative products with lower acetaminophen doses.

March 25, 2014

The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL.

SILVER SPRING, Md. — The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL. 

Atovaquone is the generic equivalent of GlaxoSmithKline's Mepron, indicated for the prevention of Pneumocystis jiroveci pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.

March 21, 2014

Actavis earlier this week announced that it has entered into an agreement with Noven Pharmaceuticals to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system).

DUBLIN — Actavis earlier this week announced that it has entered into an agreement with Noven Pharmaceuticals to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system). Daytrana is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder.

March 3, 2014

The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.

SILVER SPRING, Md. — The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties

January 31, 2014

Following the announcement that Rep. Henry Waxman, D-Calif., intended to retire, the Generic Pharmaceutical Association bid adieu to a legislator who had a tremendous positive impact on the generic industry.

WASHINGTON — Following the announcement that Rep. Henry Waxman, D-Calif., intended to retire, the Generic Pharmaceutical Association on Thursday bid adieu to a legislator who had a tremendous positive impact on the generic industry. 

January 15, 2014

Perrigo on Tuesday announced that it has received final approval for its abbreviated new drug application for fluocinonide cream 0.1%, the generic equivalent to prescription-only Vanos Cream 0.1%.

DUBLIN — Perrigo on Tuesday announced that it has received final approval for its abbreviated new drug application for fluocinonide cream 0.1%, the generic equivalent to prescription-only Vanos Cream 0.1%. 

Perrigo was awarded 180-days of generic drug exclusivity as it was the first company to submit an ANDA containing a paragraph IV certification. Perrigo had previously resolved litigation with the brand and has commenced shipment of the product.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

WASHINGTON — The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

WASHINGTON — A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

October 8, 2013

Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.

BALTIMORE — Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.

September 10, 2013

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

August 13, 2013

The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

WASHINGTON — The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

July 26, 2013

Anda VP purchasing Marc Falkin wrote in an email to coworkers and friends that he would begin working for Actavis as VP marketing, pricing and contract operations for the Parsippany, N.J.-based drug maker's generics business.

WESTON, Fla. — One of Anda's executives is moving to Actavis after 12 years at Anda.

Anda VP purchasing Marc Falkin has announced that he is leaving the company, and will join Actavis as VP marketing, pricing and contract operations for the Parsippany, N.J.-based drug maker's generics business. Anda executive director of purchasing Anthony Mihelich will assume Falkin's responsibilities in the interim.

 

July 9, 2013

The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said Tuesday.

July 9, 2013

The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

WASHINGTON — The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

June 20, 2013

Tris Pharma has hired a former buyer from AmerisourceBergen to head its generic drug business, the company said.

MONMOUTH JUNCTION, N.J. — Tris Pharma has hired a former buyer from AmerisourceBergen to head its generic drug business, the company said.

Tris announced the appointment of Janet Penner as president of the new generic pharmaceuticals business, which will have its own sales, marketing and distribution and will be responsible for bringing drugs to market. So far, the Food and Drug Administration has approved 13 of Tris' generics, including several first-to-market products.

February 28, 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

February 28, 2013

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

Leaders in both the branded and generic drug industries praised the reauthorization last June of PDUFA, the 20-year-old system by which research-based pharmaceutical companies help fund the government's expensive review and testing process for new drug applications.

February 22, 2013

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

February 6, 2013

Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

NEW YORK — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

January 16, 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

January 2, 2013

In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years.

NEW YORK — In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years. The wave of approvals poises pharmaceutical makers to see big gains after billions in losses in recent years to generic drug makers because of patent expirations.

December 28, 2012

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.