Dissolution Method Database of FDA

USFDA is one of the most user friendly regulatory website and provides all the necessary information for all class of customers ie students, patient, industrialist, generic player, innovator etc. Out of many services, one is the dissolution method database which provides all the dissolution parameters of any approved drug by just one click. This database can be explored at here

Webinar by CDER, FDA

CDER's Small Business Assistance Program introduces a new webinar, "Import of Human Drugs and Human Drug Components" which will focus on the compliance perspective of FDA’s import regulations on human drugs and human drug components. The discussion will include topics such as detention, refusal of admission, Transportation and Exportation (T&E) and Foreign Trade Zones (FTZ).


This presentation will be given by Bill Nychis, Senior Compliance Officer in the Import Operations Branch (IOB), Division of Import Operations and Recalls, Office of Drug Security, Integrity and Recalls, within the CDER Office of Compliance.

When: Thursday June 16, 2011, 11:00 AM (EDT)

It is recommended that you register and obtain your password prior to the day of the event. You can register at: Import of Human Drugs and Human Drug Products Webinar
For more information and past webinars, please visit us at: FDA Small Business Assistance: Workshops and Webinars

USFDA has started FDABasics site

The U.S. Food and Drug Administration has introduced a new Web resource called FDA Basics for Industry to help companies and others. This website link will save time and resources in their interactions with the agency.

The website is mainly filled with the basic information related to regulatory aspects of product registration from start to end and also guide the industry people for any related querries.

For more information please visit: FDABasics

Multiple 30 months stay: possible after MMA or not?

The Drug Price Competition and Patent Term Restoration Act of 1984, usually referred to as the Hatch-Waxman Act, was designed to promote generics but at the same time giving financial incentive for research and development to the innovator companies. It was changed so many times in so many manner which made very dramatic impact on the pharma industry in US.

Earlier multiple 30 month stay was allowed on filing ANDA with subsequent P IV certification due to new listing of patent in the orange book for the same product but after MMA, it is not allowed to get multiple 30 month stay.
Recently in a case FDA has allowed 30 month stay to the generics with explanation. To get full details please click here.

New anticancer hope with Sprycel (Dasatinib)

The U.S.FDA has approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first time diagnosed in patients. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a very slowly progressing blood and bone marrow disease linked to a genetic abnormality.
(Source: http://www.fda.gov/, for full detail click here)

FDA is not sure regarding bladder cancer by Actos

The U.S. Food and Drug Administration (FDA) is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone), is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.

Actos is used along with diet and exercise to control blood sugar or improve control of blood sugar in adults with type 2 diabetes mellitus.

Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the United States and is thought to be higher in diabetics.

The drug manufacturer, Takeda, has conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

At this time, FDA has not concluded that Actos increases the risk of bladder cancer. Its review is ongoing, and the Agency will update the public when it has additional information. (Source: http://www.fda.gov/)

New pediatric dosage regimen for Valcyte

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, low body surface area, and below normal serum creatinine.

The revised dosing recommendations are being updated to include an upper limit on the calculated creatinine clearance using the modified Schwartz formula, which is used to calculate the pediatric dose of Valcyte.

Valganciclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant. Cytomegalovirus is a member of a group of herpes-type viruses that can cause disease in different parts of the body. Patients with weakened immune systems, such as organ transplant patients, are particularly susceptible to CMV infection and must take medications such as Valcyte to prevent the disease.  (Source: http://www.usfda.gov/)

Merck Saphris sNDA gets FDA nod

The US Food and Drug Administration (FDA) has approved Merck's two supplemental new drug applications (sNDA's) for Saphris (asenapine) sublingual tablets to expand the product's indications.

Saphris is prescribed for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Saphris, an antipsychotic medication which works by changing the actions of chemicals in the brain, has received approval in the US on 13 August 2009.
Merck Neuroscience Clinical Research vice president David Michelson said that they look forward to discussing those new uses for Saphris with the mental health community.
(Source: http://regulatoryaffairs.pharmaceutical-business-review.com)

Bedford Labs gets US FDA nod for Sumatriptan Succinate inj in pre-filled syringes

Ohio based Bedford Laboratories, informed that the company has further diversified their product offerings with the addition of pre-filled syringes. FDA approval has been granted and Sumaptriptan Succinate injection, 6mg (base) / 0.5 mL pre-filled syringes are now available. This is a very important product addition to their expanding portfolio of products.

Sumaptriptan Succinate Injection is indicated for the acute treatment of migraine attacks with or without aura, and the acute treatment of cluster headache episodes.
Full article click here

FDA warns Novartis about facebook widget

Drug company Novartis recently received a warning letter from the Food and Drug Administration’s Division of Drug Marketing, Advertising, and Communications about a widget enabling visitors to the Web site for the company’s drug Tasigna to share information with their Facebook friends
The FDA claimed that the widget for Tasigna, a leukemia drug, violated federal regulations because it made representations about the drug’s efficacy and failed to communicate any risk information. Tasigna’s Web site offered Novartis-created information about the drug that Facebook users could “share” with their friends by posting it on their wall or sending it as a separate message. For example, one item read, “In addition to taking Tasigna (nilotinib) 200-mg capsules, talking to your doctor and receiving health tips can help you treat your CML [chronic myeloid leukemia].” For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug,” the FDA said.

Why it matters: Because drug advertising faces stricter regulation than other industries, companies have expressed concern about meeting their requirements in the world of social media. In April, pharmaceutical companies filed written statements with the FDA, urging it to adopt guidelines specific to Web marketing and the use of social media, arguing that it is impossible to convey the risk information required in other forms of advertising in a 140-character Tweet or an Internet banner ad. While the FDA has set no timetable for issuing such guidelines, its letter to Novartis – the first sent directly addressing marketing efforts on Facebook – highlights the fact that the agency is monitoring the use of social media.
For full story click here

Novartis Gets FDA Approval for Aliskiren-Amlodipine Combination

The FDA has approved Novartis’ Tekamlo, a pill containing its renin inhibitor Tekturna (aliskiren) and amlodipine (Pfizer’s Norvasc), as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. It also works as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone. For the drug to reach its full market potential, Novartis must release more outcome data, something it has committed to doing next year, Karl-Heinz Koch, an analyst at Sweden-based Helvea, said.
Form (Drug Industry Daily- fdanews)

Paragraph IV patent certification list updated

For access to the generic players regarding the paragraph IV patent certification filed against which product and on what date, FDA is publishing the list at the FDA website. It get updated twice in a month and provides recent updated list. The list in PDF format contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency. At present list is available updated till 23 August 2010.


For more details and to dowanload complete list Click here

Fixed dose combinations will be reduced in india

Since long the battle between pharmaceutical manufacturers and DCGI and FDA is going on for the issue of fixed dose combination of 2 or more drugs. The main issue was these fixed dose combination were marketed without any clinical trials. However the pharma companies were arguing that individual compounds are safe and effective and available in the market since long so the combinations are also safe.

Initially so many irrational combinations was banned by DCGI and now in the line of same, DCGI has issued a guidance for getting marketing approval of the fixed dose combinations. These guidelines apply to manufacture, import and marketing approval of fixed dose combinations as a finished pharmaceutical product considered as new drug as per Rule 122(E) of Drugs and Cosmetics Act & Rules. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) specifies the requirements for approval for marketing of various types of FDCs. The same is further described in the draft to provide a detailed guidance for industry. Finally for such FDCs clinical trials is required to be carried out right from Phase I and in order to get permission for marketing the new drug of such FDCs, along with other required documents.
So now onwards no one can manufacture such fixed dose combinations without any clinical trials data.