newsgaze » Pharma

Sun Pharma gets USFDA approval for generic Cardizem CD

Editorial Team — Tue, 01 Nov 2011 05:26:30 +0000

Sun Pharma announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Cardizem CD, Diltiazem HCl extended-release capsules are indicated in the treatment of hypertension, for the management of chronic stable angina and angina due to coronary artery spasm.

These generic Diltiazem HCl extended-release capsules, are equivalent to Valeant International’s, Cardizem CD, 120 mg, 180 mg, 240 mg, 300 mg and 360 mg. Annual sale in the US for these strengths is approximately $ 300 million.

Glenmark gets final USFDA nod for skin infection ointment

admin — Fri, 10 Jun 2011 11:00:04 +0000

GlenmarkGenerics Inc USA, the subsidiary of Glenmark Generics Limited, said it received final approval from the US health regulator United States Food and Drugs Administration (USFDA) for its generic Mupirocin ointment, used for the treatment of bacterial skin infections, said the company. Glenmark Generics Inc has been granted a final abbreviated new drug approval (ANDA) from the USFDA for Mupirocin Ointment USP 2 per cent, the company said.

Based on IMS Health sales data for the 12 month period ending March 2011, mupirocin ointment garnered annual sales of USD 55 million and achieved a 9% increase in growth compared to the same period last year. The ointment is used for treatment of impetigo, a bacterial skin infection, and is available in a 22-gram tube. The company’s current portfolio consists of 68 products authorised for distribution in the American market. It has 39 ANDAs pending approval, Glenmark said.

Jyothy Labs laundry arm acquires 100% stake in Delhi-based Diamond Fabcare

Editorial Team — Wed, 23 Mar 2011 15:11:17 +0000

Apparently eyeing to expand its presence in the markets of North India, Jyothy Laboratories’ subsidiary Jyothy Fabricare Services Limited (JFSL) has acquired 100% stake in Delhi-based laundry player Diamond Fabcare Private Limited (DFPL), the company said in a filing to the Bombay Stock Exchange. However, the company did not divulge the sum of the deal.

DFPL, the member of the US-based Dry Cleaning and Laundry Institute, has 62 outlets across Delhi, Noida, Gurgaon and Ghaziabad. The Delhi-based laundry player has a significant presence in the institutional and retail segments, with ‘Wardrobe’ being its most popular brand.

The acquisition of DFPL by Jyothy Labs arm comes within a week of Jyothy Labs acquiring a 14.9 per cent stake in Henkel India for Rs 60.73 crore. There are unconfirmed reports that Jyothy Labs may buy nearly 51 per cent stake in Henkel India.

DFPL enjoys core-competency in the laundry segment with the state-of-the-art machinery including use of 100% RO water processing, innovative supply chain system driven by sophisticated IT systems and record keeping. The laundry major also enjoys collaboration with international players for technical expertise.

“After foraying into the laundry services business nearly one-and-half years ago, we have witnessed strong growth in both institutional and retail reach. In a move to enhance our growth geographically and spread our reach in the Northern belt, we acquired the Delhi-based laundry major,” Jyothy Laboratories CMD M P Ramachandran said.

“There is lot of synergy between us and Diamond Fabcare. Our expertise and domain knowledge will help us to further grow the Northern market,” Ramachandran added.

In November, 2009, JFSL launched Fabric Spa in Bangalore with an initial investment of Rs 35 crore.

Shares of Jyothy Laboratories were trading at Rs 204.90 apiece in the late afternoon on the Bombay Stock Exchange on Tuesday, up 3.02 per cent from their previous close.

Glenmark gets USFDA nod for oral contraceptive drug Briellyn

Editorial Team — Wed, 23 Mar 2011 15:00:06 +0000

Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, announced they have been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets, their generic version of Ovcon 35 tablets by Warner Chilcott, Inc.

The product will be marketed under the trade name Briellyn and distribution is expected to start immediately in the American market, the company informed.

Briellyn provides a continuous 28-day regimen for oral contraception derived from 21 tablets composed of Norethindrone and Ethinyl Estradiol to be followed by 7 inert tablets and is indicated for the prevention of pregnancy. According to IMS Health for the 12-month period ending December 2010, this combination achieved sales of USD 30 million.

Glenmark remains the only Indian company to be granted ANDA approval for an oral contraceptive product and the approval marks their fourth female hormonal product authorized for distribution by the USFDA. The company received approval in April 2010 for Heather tablets, their generic version of Watson’s Nor-QD tablets as well as approvals in July 2010 for Norethindrone 0.35mg tablets, their generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc. and Norethindrone Acetate 5 mg tablets.

Total market sales of Glenmark’s current hormonal product line is approximately USD 141 million for the 12 month period ending December 2010, according to IMS Health. Glenmark has a number of ANDA’s currently pending approval with the USFDA in this therapeutic segment as well as a sizeable concentration of their pipeline in various stages of development.

The company’s current portfolio consists of 69 generic products authorised for distribution in the US market and over 40 ANDA’s filed with the USFDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

Venus Remedies Anti-Cancer drug ‘Gemcitabine’ gets UK MHRA approval

Editorial Team — Thu, 03 Feb 2011 04:43:02 +0000

Venus Remedies, a leading research based Indian pharmaceutical company achieved yet another landmark by receiving the Market Authorisation for GEMCITABINE, one of the key products for the treatment of Cancer via de-centralised procedure from Medicine and Healthcare Regulatory Agency (MHRA) U.K. The other countries in the list are Poland, Germany, Slovenia and Portugal for which the same feat has been achieved.

Mr Pawan Chaudhary CMD Venus Remedies said, “Venus is all set to capture substantial market share by entering the highly lucrative market of Europe as it stands amongst the first few to receive the Market Authorisation for Gemcitabine”. Gemcitabine is a $1.5 billion drug world wide with more than 30% market share from Europe.

Gemcitabine is used in the treatment of a variety of cancerous diseases including the cancer of lungs, pancreas, bladder and breast. Gemcitabine, in combination with Cisplatin, recently received FDA & EMEA approval as a first line treatment for lung cancer which is the most common form of cancer worldwide and accounts for 1.2 million fresh cases annually. GEMCITABINE, the only drug approved, has been established as the gold standard drug therapy for Pancreatic cancer (216,000 cases/annum) which has a survival rate of below 3% and is all set for explosive growth and will remain amongst the choicest of drugs even after becoming generic.

The product is available in two strength of 200mg and 1000mg and both the strengths of Venus dossier have been approved by UK MHRA authorities. Venus will produce Gemcitabine from its EU GMP approved Baddi, facility in India and planned to launch the product in UK and Germany along with other EU countries by second quarter of 2011 .

With this rare accomplishment Venus Remedies along with its illustrious product range shall now be entering the European Market through its wholly owned subsidiary Venus Pharma Gmbh.

Wockhardt to market generic version of Protonix in US

Editorial Team — Sat, 22 Jan 2011 09:51:02 +0000

Pharma and biotechnology major Wockhardt said it has received final approval from the US health regulator—US Food and Drug Administration—to market 20 mg and 40 mg generic pantoprazole (Protonix) tablets, which are used for treating ulcers and hyperacidity, in the US market.

Pantaprazole is the generic name for the brand Protonix marketed in the US by Prizer. As the patent covering this product expired on January 19, 2011, Worckhardt launched the product immediately, Wockhardt informed the Bombay Stock Exchange (BSE).

The latest market for this product in the US is about $2 billion and belongs to the class of Prolon Pump Inhibitors. The product is a delayed release tablet and requires specialised technology and manufacturing capability.

“This is yet another product that Wockhardt has been able to launch on the date of the patent expiry,” Wockhardt Chairman Habil Khorakiwala said.

He further said, “The ability to launch products on the date of patent expiry is a critical requirement to create maximum value and over the years, Wockhardt has been able to reinforce this capacity on several occasions.”

The company will manufacture the generic tablets at its US Food and Drug Administration’s certified plant at Waluj, Maharashtra.

The Mumbai-based firm also said it will manufacture pantoprazole active pharmaceutical ingredients (API) at its plant at Ankleshwar in Gujarat.

According to information services company Wolters Kluwerm, the total market for pantoprazole in the American market is nearly USD 2 billion. Shares of Wockhardt today closed at Rs 366.50 on the BSE, up 4.45 per cent from its previous close.

USFDA gives nod to Glenmark Generics’ 3 abbreviated new drug application

admin — Sat, 25 Dec 2010 11:21:33 +0000

Glenmark Generics Inc, USA, the United States subsidiary of Glenmark Generics announced that the company received approval for three abbreviated new drug application (ANDA) by the United States ood and Drug Administration (USFDA), the company informed the Bombay Stock Exchange (BSE).

Final ANDA approvals were received for Indomethacin 25 mg and 50 mg capsules, USP and Sulfamethoxazole and Trimethoprim double and single strength tablets. These products are currently available and the company has commenced shipping from their New Jersey facility. According to IMS Health, total sales achieved for the 12-month period ending September 2010 were $20 million and $31 million respectively.

Indomethacin is classified as a non-steriodal antrirheumatic and has been found effective in active stages of moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis or tendinitis) and acute gouty arthritis. Sulfamethoxazole and Trimethoprim tablets are indicated for urinary tract infections, acute otitis media, acute exacerbations of chronic bronchitis in adults, sigellosis, pneumocystis carinii pneumonia and traveler’s diarrhea in adults.

Tentative ANDA approval was granted to Glenmark for Eszopiclon, the generic version of Sepracors Lunesta, which achieved annual sales o $760 million for the 12 months period ending September 2010 according to IMS Health and is the second highest selling branded prescription medication in its class.

Earlier this year, Glenmark entered into a settlement and license agreement with Separacor to resolve a US patent infringement suit related to Glenmark’s filing an ANDA for Eszopiclone with the USFDA. Under the terms of this agreement, and upon approval and entry of a consent judgement and order of permanent injunction by the US district court for the district of New Jersey, Glenmark would be permitted to launch its generic product in November, 2013. The settlement and license agreement and Consent Judgement and Order also would permit Glenmark to launch its generic product earlier under certain circumstances.

Glenmark is currently authorized to distribute 65 products in the US.

Venus Remedies’ Phase III trials of Etimicin sulphate over

Editorial Team — Sat, 11 Dec 2010 10:37:47 +0000

Venus Remedies, a research and development-driven pharmaceutical manufacturing company, announced the successful completion of Phase III clinical trial of a novel aminoglycoside molecule, ‘Etimicin sulphate’. Etimicin sulphate, for which Venus owns the exclusive manufacturing and marketing rights in India, was licensed from a company in China in 2007.

Dr. Manu Chaudhary, JMD, Venus Remedies Ltd, says, “Etimicin Sulphate, new generation semi-synthetic aminoglycoside antibiotic has proved to be 50 % safer and more efficacious as compared to other commonly used aminoglycosides. It will provide 25% faster cure rate and is likely to reduce the treatment time.”

Etimicin has captured 80% market share of the total aminoglycoside market in China. Current size of domestic aminoglycoside formulation market in retail segment is Rs 600 crore, which is growing at 6-8 percent per annum.

“Venus is expecting to capture the same market share after Etimicin launch in domestic market that is expected in the second quarter of 2011,” Dr. Manu Chaudhary added.
Under Phase III, trials were conducted on 216 patients suffering from lower respiratory tract infections, skin and skin structure, surgical and urinary tract infections caused by pathogens. The results of the trials are encouraging, claims the company. Venus said it submitted the reports to the DCGI office. The product has undergone all requisite tests such as Sub-Acute toxicity studies to establish safety of the formulation conducted as per OECD guidelines and clinical trials for efficacy and tolerability as per ICH GCP guidelines.

The molecule is under patent protection in India, China and major markets of the world. Etimicin therapy will drastically reduce the potential risk of Nephrotoxicity and ototoxicity caused by conventional aminoglycosides like Amikacin, Tobramycin, Netilmicin etc.

Aurobindo Pharma gets USFDA tentative nod for MDD capsules

Editorial Team — Wed, 08 Dec 2010 05:26:15 +0000

Aurobindo Pharma has received tentative approval from the US Food and Drug Administration to manufacture and market Duloxetine Hydrochloride delayed release capsules.

Duloxetine Hydrochloride delayed release capsules 20 mg (base), 30 mg (base) and 60 mg (base) are the generic equivalent of Eli Lilly & Company’s Cymbalta delayed-release capsules 20 mg (base), 30 mg (base) and 60 mg (base), said the company in a filing to the BSE.

Duloxetine Hydrochloride delayed release capsules are indicated for the treatment of major depressive disorder (MDD) and falls under the neurological therapeutic category. The product has a market size of about $2.9 billion for the 12 months ending June 2010.

USFDA gives nod for Glenmark Generics’ Norethindrone contraceptive tablets

Editorial Team — Sat, 24 Jul 2010 13:21:33 +0000

Contraceptive tablets

Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, has been granted final approval by the United States Food and Drug Administration (USFDA) for Norethindrone tablets 0.35mg, the drug maker’s generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc.

Norethindrone tablets are a progestin-only oral contraceptive for the prevention of pregnancy. This is Glenmark’s third female hormonal product approval and it is the second approval for an oral contraceptive. The company received approval in April 2010 for Heather tablets, their generic version of Watson’s Nor-QD tablets and the company also got approval for Norethindrone Acetate 5mg tablets.

Glenmark remains the only Indian company to be granted an abbreviated new drug applications (ANDA) approval for a female hormonal product and an oral contraceptive product. The US contraceptive market has historically been the largest of the seven major markets with sales reaching $4.5 billion in the 12 month period ending December 2009 (MIDAS sales data, IMS Health).