USFDA has approved Jakafi (ruxolitinib) for myelofibrosis

USFDA has recently approved Jakafi (ruxolitinib), which is the first drug approved for the specific treatment of patients with the bone marrow disease myelofibrosis.
What is myelofibrosis. It is a disease in which the bone marrow is replaced by scar tissue resulting in blood cells being made in organs such as the liver and the spleen. This disease is marked by an enlarged spleen, anemia, decreased white blood cells and platelets, and myelofibrosis-related symptoms. Symptoms of  myelofibrosis
include fatigue, abdominal discomfort, pain under the ribs, feeling full (satiety), muscle and bone pain, itching, and night sweats.
(Source: www.fda.gov)

Paragraph IV certification update

USFDA has updated Paragraph IV certification list as of Nov 07, 2011. Table shows the newly added molecule.

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Pioglitazone Hydrochloride and Metformin Hydrochloride	Extended-release Tablets	15 mg/1000 mg and 30 mg/1000 mg	Actoplus Met XR	9/23/2011
Oseltamivir Phosphate	Capsules	30 mg and 45 mg	Tamiflu	8/2/2011
Doripenem	Injection	250 mg/vial and 500 mg/vial	Doribax	10/12/2011
Dasatinib	Tablets	80 mg and 140 mg	Sprycel	6/17/2011
Fluticasone Furoate	Nasal Spray	27.5 mcg	Veramyst	7/15/2011
Ketorolac Tromethamine	Opthalmic Solution	0.45%	Acuvail	8/24/2011

Paragraph IV certification update

USFDA has updated Paragraph IV certification list as of September 19, 2011. Table shows the newly added molecule.

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Mesalamine	Delayed-release Tablets	800 mg	Asacol HD	7/13/2011
Niacin and Simvastatin	Extended-release Tablets	1000 mg/40 mg	Simcor	2/4/2011

Paragraph IV certification update

USFDA has updated Paragraph IV certification list as of August 22, 2011. Table shows the newly added molecule.

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Clozapine	Orally Disintegrating Tablets	150 mg	Fazaclo	4/8/2011
Clozapine	Orally Disintegrating Tablets	200 mg	Fazaclo	4/18/2011

FDA approves Zelboraf

The USFDA has approved Zelboraf (vemurafenib), which is approved for treatment of patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

Source: www.fda.gov

Paragraph IV list update

USFDA has updated Paragraph IV certification list as of April 18, 2011. Table shows the newly added molecule.

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Glycopyrrolate	Tablets	1 mg	Robinul	8/14/2009
Glycopyrrolate	Tablets	2 mg	Robinul Forte	10/12/2010
Hydromorphone hydrochloride	Oral Solution	5 mg/5mL	Dilaudid	2/25/2011
Azithromycin	Ophthalmic Solution	1%	Azasite	3/3/2011

USFDA update

USFDA has published the list of new molecular entities (NMEs) approved by FDA's Center for Drug Evaluation and Research (CDER) during calendar year 2010.  
The list includes total 21 molecules out of which 15 are NDA approvals and rest 6 are new BLA (Biologic licence approval)
List is available here

FDA has also updated Paragraph IV certification list as of 7 February 2011. Table shows the newly added molecule.

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Oseltamivir Phosphate	Capsule	75 mg	Tamiflu	11/15/2010
Tacrolimus	Ointment	0.03%	Protopic	11/22/2010

FDA has published products identified by AERS database

FDA has posted the names of products and potential signals of serious risks/new safety information that were identified for these products during the period July - September 2010 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk.
To get the list please click here by USFDA

Paragraph IV certification updated at USFDA

The list of Paragraph IV certification is updated by FDA as of January 17, 2011 and it includes 4 new listing as below..

1) Dexlansoprazole Capsules 60 mg (RLD-Dexilant) (Date-25 Aug 2010)
2) Dutasteride and Tamsulosin Hydrochloride Capsules 0.5 mg/0.4 mg (RLD-Jalyn) (Date-26 Oct 2010)
3) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral solution 17.5 g/3.13 g/1.6 g per bottle    (RLD-Suprep Bowel Prep Kit) (Date-08 Nov 2010)
4) Voriconazole Oral suspension (RLD-Vfend) (Date- 08 Oct 2010)

In my previous post i have mentioned about the suit by pfizer for Vfend (Voriconazole) against Novartis on filing ANDA with para IV certification for Vfend oral suspension.

ABSTRAL (Fentanyl) transmucosal tablet approved by USFDA

The USFDA approved ABSTRAL (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer.  Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.
Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine.  Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use.  Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product
(Source: www.fda.gov)

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

Rosiglitazone: finally banned in india

Rosiglitazone was in media since long time due to its safety reasons all over the world. Earlier EMEA and USFDA had already suspended the marketing authorization of Rosiglitazone. Now Union health ministry of india has banned the manufacturing and distribution of Rosiglitazone.
For full article click here

New drug for treatment of HIV with lipodystrophy

The USFDA has approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.
(Source: http://www.fda.gov/)

Recent news from USFDA

The USFDA has approved Teflaro (ceftaroline fosamil), an injectable antibiotic for the treatment in adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

The USFDA has approved the cancer drug Afinitor (everolimus) to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), a rare genetic disorder. This approval was for treatments of SEGA that can not be treated with surgery.

(Source: http://www.fda.gov/)

Paragraph IV patent certification list updated

Paragraph IV patent certification list has been updated by USFDA and now its having information up to 18th october 2010. The new updation includes paragraph IV filing against Doxepin Hydrochloride Tablets and Prednisolone Sodium Phosphate Orally Disintegrating Tablets.
For full list download click here
(Source: http://www.fda.gov/)

One more obesity drug is going to be out of market

Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.
For full detail visit usfda website link here

Risk associated with Tygacil (Tigecycyline)

The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was determined using a pooled analysis of clinical trials. The cause of the excess death in these trials is often uncertain, but it is likely that most deaths in patients with these severe infections were related to progression of the infection. Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia.

FDA has updated the Warnings and Precautions and Adverse Reactions sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil. Healthcare professionals have also been informed of this increased risk. (From: USFDA)

USFDA warned consumers: Do not take TimeOut Capsules

Today in whole world people are running behind natural therapies and treatments and few peoples are taking benefit of this and supplying the products which are injurious to health under the name of natural product or dietary supplements.

Recently such case has came out and the U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement in US.


TimeOut is labeled as “100% natural” and consumers may mistakenly assume the product is harmless and poses no health risk. TimeOut is distributed on Internet sites and online marketplaces as 2,500 mg capsules.

Consumers who have TimeOut Capsules should stop using them immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or death.

The FDA analyzed TimeOut and determined that it contains hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply which can lead to dizziness or lightheadedness.

Its not mean that you stop taking care of your health and body but take the products which satisfies all the quality criteria and dont follow the markeitng tricks through advertisement in media.