Content about Pharmaceutical industry

September 23, 2013

Sandoz has launched an authorized generic drug for treating a disease commonly known as pre-leukemia, the company said on Monday.

PRINCETON, N.J. — Sandoz has launched an authorized generic drug for treating a disease commonly known as pre-leukemia, the company said on Monday.

September 23, 2013

Teva Pharmaceutical Industries has launched a generic drug for treating cardiovascular disease, the company said.

JERUSALEM — Teva Pharmaceutical Industries has launched a generic drug for treating cardiovascular disease, the company said.

Teva announced the launch of niacin extended-release tablets in the 500-mg, 750-mg and 1,000-mg strengths. As the first company to file for approval of the drug, Teva will have 180 days in which to market the generic version exclusively.

September 20, 2013

Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said.

ALLEGAN, Mich. — Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said Friday.

The Allegan, Mich.-based drug maker announced the appointment of Keith Webber as head of regulatory review, a position in which he will start on Oct. 21. Webber previously served as acting director of the FDA's Office of Pharmaceutical Science, part of the Center for Drug Evaluation and Research, which regulates prescription and OTC drugs. He also served as director of the Office of Generic Drugs.

September 19, 2013

A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

WASHINGTON — A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

September 17, 2013

The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

The FDA approved zolpidem tartrate extended-release tablets in the 6.25-mg and 12.5-mg strengths, a generic version of Sanofi's Ambien CR.

The branded version of the drug had sales of $366 million during the 12-month period ended in March, according to IMS Health.

 

September 17, 2013

The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

JERUSALEM — The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

The Israeli drug maker announced the approval of a liquid formulation of Treanda (bendamustine hydrochloride), which it said would eliminate the need for reconstitution.

The drug is used to treat indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with Rituxan (rituximab), which is made by Genentech and Biogen Idec, and in patients with chronic lymphocytic leukemia.

September 16, 2013

Actavis has launched a generic drug for post-shingles pain under an agreement with the branded drug's manufacturers, the company said Monday.

PARSIPPANY, N.J. — Actavis has launched a generic drug for post-shingles pain under an agreement with the branded drug's manufacturers, the company said Monday.

Actavis announced the launch of generic lidocaine topical patches in the 5% strength under a settlement agreement with Endo Pharmaceuticals and Teikoku Seiyaku Co. The drug is a generic version of Lidoderm, and Actavis said it was likely the first company to win approval for the generic from the Food and Drug Administration, thus entitling it to 180 days in which to compete exclusively against the branded version.

September 16, 2013

The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

The FDA announced the approval of Teva Pharmaceutical Industries' capecitabine tablets in the 150-mg and 500-mg strengths. The drug is used to treat cancers that have metastasized, meaning they've spread to other parts of the body.

The drug is a generic version of Xeloda, made by Roche division Genentech. According to IMS Health, Xeloda had sales of $706.2 million last year.

 

September 16, 2013

The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

MUMBAI, India — The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

Sun announced the approval of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths.

The drug is a generic version of Takeda's Prevacid delayed-release capsules, which are used for treatment lasting up to four weeks for healing and symptom relief of active duodenal ulcers.

Various versions of the drug have annual sales of about $430 million per year, according to Sun.

 

September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

SILVER SPRING, Md. – The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

September 12, 2013

The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

SILVER SPRINGS, Md. — The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

In a memo to staff of the agency's Center for Drug Evaluation and Research, center director Janet Woodcock wrote that for fiscal year 2013, the FDA hired 234 people as part of the Generic Drug User Fee Amendments Human Capital Team. The goal was to hire 231 as part of a three-year push in which it hopes to hire 921, including 461 during fiscal year 2014.

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.

September 10, 2013

A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK's Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.

September 10, 2013

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

September 10, 2013

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff.

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff. One of the reasons why generic prescriptions will likely peak at 86% to 87%, Long said, is that after the patent on Crestor expires In 2016, there simply won't be a lot of top-selling branded drugs.

September 10, 2013

Drug maker Depomed has expanded the geographic scope of a license agreement it has with Merck for diabetes drugs, the company said.

NEWARK, Calif. — Drug maker Depomed has expanded the geographic scope of a license agreement it has with Merck for diabetes drugs, the company said.

The licensing agreement, which the two companies entered in July 2009, gives Merck a non-exclusive license and other rights to certain Depomed patents for extended-release metformin, while Depomed will receive "modest" royalties on net product sales of the drug Janumet XR (sitagliptin; metformin hydrochloride) in countries in which the licensed patents cover the product.

September 10, 2013

Generic drugs have been on a roll with their share of total prescriptions dispensed in the country seeming to increase on a nearly constant basis. But it appears the peak is coming soon.

Generic drugs have been on a roll with their share of total prescriptions dispensed in the country seeming to increase on a nearly constant basis. But it appears the peak is coming soon.

(For the full category review, including sales data, click here.)

September 10, 2013

Teva Pharmaceutical Industries has introduced a generic version of an antibiotic drug kit, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has introduced a generic version of an antibiotic drug kit, the company said.

Teva, through U.S. subsidiary Teva Pharmaceuticals, announced the introduction of 30-mg lansoprazole delayed-release capsules, 500-mg amoxicillin capsules and 500-mg clarithromycin tablets. The treatment is packaged in 14 cards with eight pills, designed for 14 days of treatment.

The treatment is a generic version of Takeda's Prevpac Kit.

 

September 3, 2013

Over the last few years, many drug makers have offered coupons and co-payment-assistance programs as a way to reduce patients' out-of-pocket spending on medications, but a new study questions whether they really reduce spending in the long run and whether they're even legal.

NEW YORK — Over the last few years, many drug makers have offered coupons and co-payment-assistance programs as a way to reduce patients' out-of-pocket spending on medications, but a new study questions whether they really reduce spending in the long run and whether they're even legal.

August 28, 2013

The global market for drug packaging is expected to experience tremendous growth over the next few years, according to a new report.

NEW YORK — The global market for drug packaging is expected to experience tremendous growth over the next few years, according to a new report.

August 27, 2013

AstraZeneca has bought Maryland-based biotech company Amplimmune, the drug maker said.

LONDON — AstraZeneca has bought Maryland-based biotech company Amplimmune, the drug maker said.

AstraZeneca announced the acquisition of privately owned Amplimmune through its MedImmune biologics research and development subsidiary, saying it would boost its cancer drug pipeline. Amplimmune's pipeline includes several experimental treatments, such as AMP-514, a monoclonal antibody currently in preclinical development for which the company hopes to apply to start clinical trials before the end of the year.

August 27, 2013

Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

NEW YORK — Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

August 26, 2013

Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

THOUSAND OAKS, Calif. — Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

Onyx, based in South San Francisco, Calif., has a portfolio of cancer drugs, including the injected multiple myeloma drug Kyprolis (carfilzomib), as well as Nexavar (sorafenib) tablets, developed with Bayer HealthCare Pharmaceuticals; Stivarga (regorafenib) tablets, developed by Bayer; and palbociclib, developed by Pfizer.

August 20, 2013

The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical Cos., the drug maker said Tuesday.

Par announced the approval of bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL and is used to treat major depressive disorder. The company already markets the generic drug in the 150-mg strength.