The USFDA has approved (Final approval) following generics:
1. Betamethasone Dipropionate Topical Cream 0.05%, Glenmark Generics
2. Didanosine Delayed-Release Capsules (125, 200, 250, 400 mg), Aurobindo Pharma
3. Nabumetone Tablets (500 and 750 mg), Dr. Reddy's Lab
Committee for Medicinal Products for Human Use (CHMP) recommended to grant a marketing authorisation for the following medicinal products:
1. Vildagliptin/metformin hydrochloride (Zomarist) 50 mg+850 mg and 50 mg+1000 mg, film-coated tablet: (Novartis )
2. Zypadhera, 210 mg, 300 mg, 405 mg powder for suspension for injection intended for treatment of schizophrenia: (Eli Lilly )
3. Xiliarx 50 mg tablets intended for treatment of type 2 diabetes mellitus:(Novartis Europharm Ltd.)
4. Irbesartan 75 mg , 150 mg and 300 mg film-coated tablets :(Krka)
5. Brinzolamide and Timolol (Azarga) 10 mg/ml / 5 mg/ml Eye drops, suspension intended the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension: (Alcon)
6. Tetrahydrobiopterin (Kuvan), 100 mg, soluble tablets intended for the treatment of hyperphenylalaninemia (HPA):(Merck KGaA)
Final Approval
Amiodarone Hydrochloride 200 mg Tablets (Zydus)
Protriptyline Hydrochloride 5 mg and 10 mg Tablets (Roxane)
Carbidopa and Levodopa Orally Disintegrating Tablets (10: 100 mg, 25:100 mg, 25: 250 mg) (Mylan Pharma)
Tentative Approval
Ziprasidone Hydrochloride Capsules 20 mg, 40 mg, 60 mg and 80 mg(Sandoz)
The Indian Pharma giant, which is sccaner for allegedly falsifying records that resulted in the sale of generic, has hired Mr. Rudy Giuliani to provide advice and review compliance issues
Ranbaxy Laboratories Ltd., today announced that they have retained the services of former New York City Mayor Rudy Giuliani and Giuliani Partners to provide advice and review compliance issues related to the recent United States Food and Drug Administration letters and Import Advisory.In announcing the addition of Mayor Giuliani, Ranbaxy reiterated its commitment to work cooperatively with the FDA to address the Import Advisory and put into place measures which will allow its products identified on the Advisory to be released into the US marketplace.As the FDA stated, all drugs manufactured by Ranbaxy have repeatedly tested safe and effective with no adverse incidents reported. Ranbaxy is committed to a swift resolution to address these issues and to continuing to supply the global marketplace with safe and effective pharmaceuticals
This is the second time the former New York City mayor has acted as a paid consultant to a troubled drugmaker. Eralier he worked for Prudue Pharma, which was fined for its Oxycontin marketing, and he helped negotiate a deal with federal prosecutors that kept company execs out of jail
1. Galantamine Hydrobromide Extended-Release Capsules 8 mg, 16 mg and 24 mg, Barr Lab got Final Approval (With FTF 180 days exclusivity), Earlier news of IPPharmdoc on this product Here
2. Hydralazine Hydrochloride Tablets, Hetero Drugs, Ltd., Approval
3. Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Approval
4. Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories, Ltd., (Tentative Approval)
5. Aurobindo Pharma has received the tentative approval to manufacture and market Abacavir sulfate tablets 60mg from the US Food & Drug Administration (US FDA). The company had earlier received tentative approvals to Abacavir sulfate tablets 300mg and Abacavir sulfate oral solution 20mg/mL.
In response to a U.S. Food and Drug Administration (USFDA) press release today announcing warning letters and Import Alert for Drugs issued to Ranbaxy Laboratories Ltd regarding drug products produced in two Ranbaxy plants in India, the company issued the following statement:
“Ranbaxy is very disappointed in the action FDA has taken today. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made. We are, however, pleased that FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs. The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues.”
According to the USFDA announcement, the warning letters and Import Alert do not apply to Ranbaxy’s other facilities including its three manufacturing facilities in the U.S., Ohm’s Laboratories facilities in New Brunswick, NJ, North Brunswick, NJ, and Gloversville, NY, from which Ranbaxy delivers some 59 drug products to the U.S. healthcare system, including: Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended release tablets, Lisinopril and Zolpidem.
(Source: Ranbaxy Press Release Here)
The U.S Food and Drug Administration (USFDA) today issued two Warning Letters to Ranbaxy Lab, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.
The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.
The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.
Today's announcement does not impact products from Ranbaxy's otherplants which are not affected by today's actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.
The FDA recommends that consumers continue taking their medications manufactured by Ranbaxyand not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.
Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA's drug compliance office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products
Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.
The FDA Import Alert covers more than 30 different generic drug products produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.
"With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research (CDER). "The FDA has notified other agencies and health care professionals to make them aware of today's actions so that they can take appropriate action and advise patients as needed." The Warning Letters issued today document the results of FDA investigations at these two sites.
One Warning Letter addressed problems at Ranbaxy's Dewas facility found during an inspection conducted by FDA in early 2008. During that inspection, FDA investigators documented significant cGMP deviations in the manufacture of sterile and non-sterile finished products and violations with respect to the manufacture and control of APIs. Specific areas of concern included the following aspects of the firm's quality control program:
· The facility's beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
· Inadequate batch production and control records;
· Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
· Inadequate aseptic (sterile) processing operations.
The second Warning Letter addressed the Paonta Sahib facility following an inspection at its Batamandi unit, also in early 2008.This inspection documented various cGMP deficiencies, including the following:
· The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;
· Inaccurate written records of the cleaning and use of major equipment;
· Incomplete batch production and control records; and,
· Inadequate procedures for the review and approval of production and control records for drug products.
Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for each of the facilities. In mid-April and May, Ranbaxy responded in writing to these findings in lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy's responses, and the firm's overall inspectional history, an evaluation that required substantial time due to the complex scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and the firm's responses. Ultimately, FDA concluded that the firm's responses were not adequate and that the Warning Letters were the appropriate regulatory response.
"Today's actions are clearly warranted by the serious violations established by FDA's investigations at these two sites," said Deborah M. Autor, director, CDER's Office of Compliance, FDA. "Until the company addresses these deficiencies, APIs and finished drug products from these plants will remain on the Import Alert, and we will not approve any Abbreviated New Drug Applications or New Drug Applications that list either of the two facilities as the manufacturer of APIs or finished drug products."
This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.
Warning letter for Dewas facility Here
Warning letter for Paonta Sahib facility Here
List of drugs affected Here
Question and answers on this issue Here
Earlier report of IPPharmadoc on this issue Here
(Source: Press release from USFDA)
Jerusalem, Israel, September 14, 2008 Teva Pharma announced today that following a hearing on September 12, 2008, the U.S. Court of Appeals for the District of Columbia has vacated an April 2008 ruling, which granted Teva 180-day exclusivity for its Risperidone Tablets, AB-rated to Janssen's Risperdal® Tablets. As a result of this decision, the U.S. Food and Drug Administration is no longer enjoined from approving subsequent Abbreviated New Drug Applications (ANDA).
Earlier news of IPPharmadoc on Risperidone Here
(Source: Press release from Teva)
Teva is first para IV filer for Montelukast tablets 4 and 5 and 10 mg/tablet. Teva filed ita ANDA with para IV certification on December, 2006 against following Orange Book listed patent:
US5565473 (Expiry: 8/3/2012): which covers unsaturated hydroxyalkylquinoline acids as leukotriene antagonists, including Montelukast as product.
Innovator sued Teva on April, 2007 for the infringement of '473 patent. The case is ongoing at New Jersey District Court (Discovery phase).
Now, Teva has came up with strong invalidation grounds against said patent with allegation of intent to deceive USPTO against innovator, during prosecution of '473 patent
Teva has requested court that Merck withheld two important prior art documents authored by Merck's scientist Dr Robert Young during prosecution of said patent. The hearing for this case is scheduled in October, 2008.
If Teva succeed in its attempt, then generic space will open early for this product in US market
Salix Pharma announced that it as filed a lawsuit in the United States District Court for the District of New Jersey against generic player Novel Labs for infringement of only Orange Book listed patent US5616346 for OSMOPREP(R) (Sodium phosphate monobasic monohydrate 0.398g, USP and Sodium Phosphate dibasic anhydrous, USP, 1.102g) Tablets. Novel Labs recently filed ANDA with Para IV certification against following orange book listed patent:
US5616346 (Expiry: May 18, 2013): which covers an orally administrable composition capable of dispersal in the stomach for inducing purgation of the colon in humans consisting essentially of an effective colonic purgative amount of at least one sodium phosphate salt wherein said composition is in a non-aqueous form selected from the group consisting of tablets and gelatin capsules and wherein one or more additives selected from the group consisting of buffering agents, dispersal agents and binding agents are optionally present.
Earlier, Innovator got approval for this product on March 16, 2006
After acquiring some of the best innovator industries like Pharmacia and Warner-Lambert, Pfizer is now ready to acquire another pharma giant Bayer pharma (worth $ 57 billion, Reuter report). Recently, some innovator and generic companies have acquired their rival companies as reported earlier by IPPharmadoc Here, Here, Here, here, Here
Innovator Forest Lab announced that an Office Action in the Reexamination of Orange Book listed patent US6545040 was received from the U.S. Patent and Trademark Office (USPTO) by Janssen Pharma the patent holder of the '040 patent. In the Office Action, the USPTO has rejected all of the pending claims as unpatentable in view of the cited prior art US4654362
Nebivolol was approved for 2.5, 5 and 10-mg/tablet formulation by USFDA on Dec 17, 2007. The NCE exclusivity for this product will expire on Dec 17, 2012.
There are two orange book listed patents for this product
US5759580 (Expiry: Jun 2, 2015): which covers a pharmaceutical composition comprising a pharmaceutically acceptable carrier and as active ingredient nebivolol or a pharmaceutically acceptable salt thereof characterized in that the active ingredient is in a micronized solid form and wherein the pharmaceutically acceptable carrier comprises a filler, lubricant, disintegrate, binding agent and wetting agent.
US6545040 (Expiry: Apr 8, 2020): which covers A composition consisting of the compound [2R,.alpha.S,2'S,.alpha.'S]-.alpha.,.alpha.'-[iminobismethylene]bis[6-fluo ro-3,4-dihydro-2H-1-benzopyran-2-methanol]
Eralier, the European equivalent of ‘040 patent EP0334429 was invalidated by a UK court on complaint by Actavis pahrma, as reported earlier by Ippharmadoc Here
A federal district court judge has ruled that three antitrust cases against Barr Pharmaceuticals filed by direct purchasers cannot be decided on summary judgment.
Meijer, Walgreen and CVS Pharmacy filed the suit in the U.S. District Court for the District of Columbia claiming that Barr and Warner Chilcott made an illegal agreement to delay the introduction of generic Ovcon (ethinyl estradiol/norethindrone) in 2004.
Link to full news Here
Teva Health Systems announced the introduction and availability of the first generic Nicardipine Hydrochloride Injection. This product is AP rated to Cardene I.V. Nicardipine HCl Injection. The injection is available as 2.5 mg/mL-25 mg, in single dose amber glass vials.
Biovail Corporation announced that the USFDA has accepted the Company's abbreviated new drug application (ANDA) for a generic formulation of 145mg and 48mg strengths of fenofibrate tablets (sold under the brand name Tricor by Abbott Laboratories). This drug has around $1.5 billion sale in US.
USFDA granted tentative approval for the first generic combination formulation of Abacavir sulfate and Lamivudine tablets (600 mg +300 mg), manufactured by Aurobindo Pharma Limited, Hyberdad, India. This drug was approved under President’s Emergency Plan for AIDS Relief (PEPFAR)
