USFDA: New and Generic Drug Approvals: 25 SEP 2014

New and Generic Drug Approvals

September 25, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Abacavir Sulfate; Lamivudine	abacavir sulfate;lamivudine	Tablet;Oral	Hetero Labs Ltd V	Tentative Approval
Betoptic	betaxolol hydrochloride	Solution/Drops;Ophthalmic	Alcon	Manufacturing Change or Addition
Brovana	arformoterol tartrate	Solution;Inhalation	Sunovion	Manufacturing Change or Addition
Dextrose 5% and Potassium Chloride 0.075% In Plastic Container	dextrose; potassium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Dextrose 5% and Potassium Chloride 0.15% In Plastic Container	dextrose; potassium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Dextrose 5% and Potassium Chloride 0.224% In Plastic Container	dextrose; potassium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Dextrose 5% and Potassium Chloride 0.3% In Plastic Container	dextrose; potassium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Fludeoxyglucose F 18	fludeoxyglucose f 18	Injectable;Injection	Massachusetts General Hosp	Approval
Genotropin	somatropin recombinant	Injectable;Injection	Pharmacia and Upjohn	Labeling Revision
Genotropin Preservative Free	somatropin recombinant	Injectable;Injection	Pharmacia and Upjohn	Labeling Revision
Minocycline Hydrochloride	minocycline hydrochloride	Tablet, Extended Release;Oral	Ranbaxy Labs Ltd	Approval
Mitosol	mitomycin	For Solution;Topical	Mobius Therap	Labeling Revision
Norditropin	somatropin recombinant	Injectable;Injection	Novo Nordisk Inc	Labeling Revision
Norditropin Flexpro	somatropin recombinant	Injectable;Injection	Novo Nordisk Inc	Labeling Revision
Norditropin Nordiflex	somatropin recombinant	Injectable;Injection	Novo Nordisk Inc	Labeling Revision
Phentermine Hydrochloride	phentermine hydrochloride	Tablet;Oral	Ken Lifescience	Approval
Phentermine Hydrochloride	phentermine hydrochloride	Capsule;Oral	Ken Lifescience	Approval
Premarin	estrogens, conjugated	Cream;Topical, Vaginal	Wyeth Pharms Inc	Manufacturing Change or Addition
Qoliana	brimonidine tartrate	Solution/Drops;Ophthalmic	Alcon Pharms Ltd	Manufacturing Change or Addition
Tasigna	nilotinib hydrochloride monohydrate	Capsule;Oral	Novartis	Labeling Revision
Timolol Maleate	timolol maleate	Solution, Gel Forming/Drops;Ophthalmic	Falcon Pharms	Manufacturing Change or Addition
Uceris	budesonide	Tablet, Extended Release;Oral	Santarus Inc	Manufacturing Change or Addition
Zinacef	cefuroxime sodium	Injectable;Injection	Covis Injectables	Labeling Revision
Zinacef	cefuroxime sodium	Injectable;Intramuscular, Intravenous	Covis Injectables	Labeling Revision
Zinacef In Plastic Container	cefuroxime sodium	Injectable;Injection	Covis Injectables	Labeling Revision

EMEA : 15 Medicines set for EMEA Approval...

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended a stream of new products for approval within the region, with a group of 15 now having jumped the final hurdle before an ultimate decision from regulators.

First up, Gilead’s Harvoni

(sofosbuvir/ledipasvir) has been backed for clearance to treat adults with hepatitis C (HCV). The drug belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates, and marks the third new therapy for the disease put forward by the CMHP in the last few months.

Next, Laboratoire HRA Pharma’s Ketoconazole HRA (ketoconazole) has been recommended as a ‘new’ treatment for patients with the rare hormonal disorder Cushing’s syndrome. The drug, normally used to fight fungal infections (though no longer by mouth because of liver injury risk), has actually been used off-label to treat Cushing’s for more than 30 years, but it has never been formally approved for this indication.

Two cancer drugs have also won CHMP backing - Boehringer Ingelheim’s Vargatef (nintedanib) for the treatment of non-small cell lung cancer and Eli Lilly’s Cyramza (ramucirumab) for gastric cancer. The diagnostic agent Lymphoseek (tilmanocept) was also endorsed for the delineation and localisation of sentinel lymph nodes.

According to BI, Vargatef, when added to docetaxel, is the first lung cancer treatment to have provided over one-year overall survival for patients with advanced adenocarcinoma, after first-line chemotherapy. And with regard to Lilly’s biologic Cyramza, clinical data show that adding the drug to paclitaxel significantly boosted median overall survival in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma.

Elsewhere, the CHMP also recommended: Teva’s Egranli (balugrastim) for chemotherapy-induced neutropenia, as well as Almirall's Brimica Genuair and Duaklir Genuair (aclidinium/formoterol) for maintenance bronchodilator treatments to relieve symptoms of chronic obstructive pulmonary disease and asthma; Janssen’s Rezolsta (darunavir/cobicistat) for HIV; Eli Lilly’s Trulicity (dulaglutide) for type II diabetes; AstraZeneca’s Moventig(naloxegol) for opioid-induced constipation; and Generics (UK)’s generic Tadalafil Mylan for erectile dysfunction in adult males; 

Three hybrid applications have also received the thumbs up: Budesonide/Formoterol Teva and Vylaer Spiromax for the treatment of asthma and severe COPD, and Budesonide/Formoterol Teva Pharma B.V. for the treatment of asthma. Hybrid applications rely in part on the results of preclinical tests and clinical trials for a reference product and in part on new data, the Committee said.

USFDA : Social Media Promotion !!! OPDP Reopens Comment Period for Two Draft Social Media Guidances...

In response to a request for additional time and to allow interested persons more time to submit comments, FDA is reopening the comment period for the two draft social media guidances that published on June 17, 2014.

Beginning September 29, 2014, the public will have an additional 30 days to provide comments on the draft guidances—“Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”

To view USFDA's Social Media Guidances Webpage CLICK HERE

CFSAN Constituent Update - Food Facility Biennial Registration Renewal

Food facilities required to register with FDA must renew their food facility registrations this year during the period beginning on October 1, 2014 and ending on December 31, 2014. FDA encourages food facilities to renew their registrations early on in the three-month renewal period.

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended the food facility registration requirements of section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apply to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year.

FDA has three guidance documents available to provide assistance to registrants with the registration process, including information on biennial registration renewal. These guidance documents are listed below.

The Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide was updated in 2012 to reflect FSMA amendments to the FD&C Act, and contains information regarding: who is required to register and who may be exempt; how often facilities must register and renew registrations; when FDA may suspend a registration; and how facilities may submit their registrations and registration renewals to FDA.

The Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition)was updated in 2012 and contains helpful questions and answers regarding food facility registration. Updates to questions in this edition are based on FSMA amendments.

The Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrationcontains information regarding food-product categories included in the food facility registration form.

USFDA: New and Generic Drug Approvals: 24 SEP 2014

New and Generic Drug Approvals

September 24, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Armodafinil	armodafinil	Tablet;Oral	Teva Pharms Usa Inc	Tentative Approval
Benzonatate	benzonatate	Capsule;Oral	Thepharmanetwork Llc	Approval
Diovan	valsartan	Capsule;Oral	Novartis	Labeling Revision
Diovan Hct	hydrochlorothiazide; valsartan	Tablet;Oral	Novartis	Labeling Revision
Exforge	amlodipine besylate; valsartan	Tablet;Oral	Novartis	Labeling Revision
Exforge Hct	amlodipine besylate; hydrochlorothiazide; valsartan	Tablet;Oral	Novartis	Labeling Revision
Fortaz	ceftazidime	Injectable;Injection	Covis Injectables	Labeling Revision
Fortaz In Plastic Container	ceftazidime sodium	Injectable;Injection	Covis Injectables	Labeling Revision
Fosrenol	lanthanum carbonate	Tablet, Chewable;Oral	Shire Llc	Labeling Revision
Fosrenol	lanthanum carbonate	Powder;Oral	Shire Development	Labeling Revision
Naftin	naftifine hydrochloride	Gel;Topical	Merz Pharms	Manufacturing Change or Addition
Raloxifene Hydrochloride	raloxifene hydrochloride	Tablet; Oral	Invagen Pharms	Approval
Spiriva Respimat	tiotropium bromide	Spray, Metered;Inhalation	Boehringer Ingelheim	Approval
Sterile Water In Plastic Container	sterile water for irrigation	Liquid;Irrigation	Hospira	Manufacturing Change or Addition
Tybost	cobicistat	Tablet;Oral	Gilead Sciences Inc	Efficacy Supplement with Clinical Data to Support
Velphoro	sucroferric oxyhydroxide	Tablet, Chewable;Oral	Vifor Fresenius	Labeling Revision
Vibramycin	doxycycline hyclate	Injectable;Injection	Pfizer	Labeling Revision
Vitekta	elvitegravir	Tablet;Oral	Gilead Sciences Inc	Approval
Xylocaine Viscous	lidocaine hydrochloride	Solution;Oral	Fresenius Kabi Usa	Labeling Revision

USFDA approves AbbVie's HUMIRA® (adalimumab) for the Treatment of Pediatric Patients with Moderately to Severely Active Crohn's Disease

AbbVie announced today that the U.S. Food and Drug Administration (FDA) has approved HUMIRA^® (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for HUMIRA in the United States and makes it the first and only biologic treatment approved for use in this patient population that can be administered at home.

-- HUMIRA is now indicated to treat pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate

-- HUMIRA is the first biologic approved in the U.S. that can be administered at home for the treatment of moderately to severely active Crohn's disease in pediatric patients
-- FDA granted HUMIRA Orphan Drug Designation for pediatric Crohn's disease

"Moderate to severe Crohn's disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "The approval of HUMIRA for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease."

For information CLICK HERE

TGA : Launched a new online service to make it easier for consumers to report side effects from medicines

The Therapeutic Goods Administration (TGA) has launched a new online service to make it easier for consumers to report side effects from medicines and vaccines.

The TGA said adverse events were under-reported around the world with 90 to 95 per cent estimated to go unreported to regulators.

"There is an international trend for regulators to encourage reporting by consumers and the release of the new consumer-focused web reporting option forms part of the TGA's effort," the TGA said.

ach year, the TGA receives more than 17,000 reports of suspected adverse events to medicines and vaccines.

In 2013, about 3 per cent of these reports came from consumers, compared with 55 per cent coming via pharmaceutical companies, 17 per cent from State and Territory Health Departments, 10 per cent from hospitals and hospital pharmacists and the remainder from community pharmacists and general practitioners.

"The new web-based reporting service for consumers is one of a range of initiatives being implemented by the TGA to encourage reporting among this group," the TGA said.

Other activities include a brochure outlining to the public what and how to report side effects, awareness activities and consumer research to help plan further projects to raise awareness.

The new online service can be found at this PS News link and the brochure here.

USFDA : Draft Guidance for Industry : Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices

A draft guidance has been posted titled, "Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices."  FDA is issuing this guidance to provide industry and agency staff with recommendations for 100 the suggested format and content of an Abbreviated 510(k) submission for early growth 101 response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen 102 characterization devices and recommendations for addressing certain labeling issues relevant 103 to the review process specific to these devices.  

To view/download the draft guidance, please CLICK HERE

USFDA : Paragraph IV Patent Certifications

To Download List of Paragraph IV Patent Certifications as on 23 Sep 2014 CLICK HERE

MHRA announces new guidance on reporting suspected adverse drug reactions in children and neonates

MHRA has announced new simplified guidance for healthcare professionals reporting suspected adverse drug reactions (ADRs) in children to its Yellow Card Scheme.

Changes to the guidelines follow a recent workshop with paediatric specialists, healthcare professionals and patient organisations who concluded that reporting all suspected ADRs in children was considered impractical for busy healthcare professionals and potentially acted as a barrier to reporting.

The new guidance is simpler and aligned with the reporting guidelines for adults. It asks that healthcare professionals report all suspected ADRs that are serious, medically significant or result in harm, and all those that are associated with newer drugs and vaccines identified by the black triangle symbol.

This guidance applies to medicines, vaccines, herbal or complementary products, whether self-medicated or prescribed, and includes suspected ADRs associated with misuse and unlicensed medicines.

It also places greater importance on the reporting of medication errors in children resulting in suspected ADRs, and provides information on why reporting these reactions in children and neonates is particularly important.

Director of Vigilance and Risk Management of Medicines, Dr June Raine said:

“We strongly encourage healthcare professionals to help improve adverse drug reaction data by reporting suspected adverse drug reactions in children and neonates using the new simplified guidance.

“The effects of medicines in children can be different to adults and in order to widen our knowledge on any possible side effects in this young age group for existing and new drugs, it is vital that we receive reports.

“The quickest way to send a Yellow Card is online at mhra.gov.uk/yellowcard. Healthcare professional should inform patients about the Scheme and encourage them to also report themselves.”

Dr Hilary Cass, President of the Royal College of Paediatrics and Child Health, said:

“Reporting adverse reactions quickly and accurately is key to ensuring medicines are safe and effective for children and young people. These new guidelines should help speed up the process and mean that healthcare professionals are not put off by complex forms and unclear processes  The key message is – if you suspect a serious adverse drug reaction in a child – it must be reported and the best way of doing so it via the online Yellow Card.”

For details on Guidance Document CLICK HERE