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USFDA approves Indoco’s Allopurinol ANDA
Indoco Remedies Limited (India) | Facebook
https://www.facebook.com/Indoco-Remedies-Limited-India-317944458228011/
USFDA approves Indoco’s Allopurinol ANDA… Indoco Remedies Limited (India)’s … Indoco Remedies Limited (India) added a new photo
Allopurinol, sold under the brand name Zyloprim and generics, is a medication used primarily to treat excess uric acid in the bloodand its complications, including chronic gout. It is a xanthine oxidase inhibitor and is administered orally.
It is on the World Health Organization’s List of Essential Medicines, a list of the most important medication needed in a basic health system.
Allopurinol has been marketed in the United States since August 19, 1966, when it was first approved by FDA under the trade name Zyloprim. Allopurinol was marketed at the time by Burroughs-Wellcome. Allopurinol is now a generic drug sold under a variety of brand names, including Allohexal, Allosig, Milurit, Alloril, Progout, Ürikoliz, Zyloprim, Zyloric, Zyrik, and Aluron
Aditi Kare Panandikar, Managing Director, Indoco Remedies
click above
///////////Indoco Remedies Ltd, USFDA, approves, Indoco’s, Allopurinol, ANDA, Aditi Kare Panandikar, Managing Director,
Glenmark Generics receives final ANDA approval for Telmisartan Tablets
Glenmark Generics receives final ANDA approval for Telmisartan Tablets
Mumbai, India, July 8, 2014
Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately.
Telmisartan Tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis®. Telmisartan is indicated for the treatment of hypertension.
The approval is for the 20mg, 40mg and 80mg tablets. For the 12 month period ending March 2014, Telmisartan garnered annual sales of USD 250 Million according to IMS Health.
Glenmark receives USFDA approval for telmisartan tablets
Telmisartan, which is the generic version of Boehringer Ingelheim’s Micardis, garnered annual sales of $ 250 million for the 12 month period ending March 2014
Glenmark receives final ANDA approval for Desoximetasone Ointment USP, 0.25%
Desoximetasone 382-67-2 cas
September 23, 2013: Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food
and Drug Administration (U.S. FDA) for Desoximetasone Ointment USP, 0.25% their generic version of Topicort® by Taro Pharmaceuticals USA Inc and shipping will commence immediately.
Desoximetasone Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. According to IMS Health sales data for the
12 month period ending June 2013, Desoximetasone Ointment garnered annual sales of approximately USD 40 million.
more info
Desoximetasone is a medication belonging to the family of medications known as topical corticosteroids. It is used for the relief of various skin conditions, including rashes. It helps to reduce redness, itching, and irritation. Desoximetasone is a synthetic corticosteroid, a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.
There are two brand name products:
- Topicort Emollient Cream (0.25% desoximetasone)
- Topicort LP Emollient Cream (0.05% desoximetasone)
When using desoximetasone, some of the medication may be absorbed through the skin and into the bloodstream. Too much absorption can lead to unwanted side effects elsewhere in the body. To keep this problem to a minimum, avoid using large amounts of desoximetasone over large areas, do not use it for extended periods of time, and do not cover it with airtight dressings such as plastic wrap or adhesive bandages unless specifically told to by your doctor. Children may absorb more medication than adults do. Desoximetasone is for use only on the skin and should be kept out of the eyes.
Desoximetasone can also be used to treat some types of psoriasis.
Watson Files ANDA for Ranbaxy’s Absorica
isotretinoin
RANBAXY RECEIVES PARAGRAPH IV CERTIFICATION
Gurgaon, India, Sept. 19, 2013 – Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited, today announced that the company has received a Paragraph IV Certification Notice of filing from Watson Laboratories Inc. of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) for a generic version of Absorica™ (isotretinoin capsules), a product that is licensed from Cipher Pharmaceuticals Inc. (TSX: DND) (”Cipher”) of Mississauga, Ontario. read all a thttp://www.pharmalive.com/watson-files-anda-for-ranbaxys-absorica
Isotretinoin, INN, /ˌaɪsoʊtrɨˈtɪnoʊ.ɨn/, first marketed as Accutane by Hoffmann-La Roche, is a medication primarily to curecystic acne. Rarely, it is also used to prevent certain skin cancers (squamous-cell carcinoma), and can be used in the treatment of brain, pancreatic and other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body.
Isotretinoin is currently the standard of care for treatment of severe, scarring cystic acne. The most common adverse effects are a transient worsening of acne (lasting 2–3 weeks), dry lips (cheilitis), dry skin, and a propensity to sunburn easily. Other side effects are rare but do include: muscle aches and pains (myalgias), headaches. Isotretinoin is known to cause birth defectsdue to in utero exposure because of the molecule’s close resemblance to retinoic acid, a natural vitamin A derivative which controls normal embryonic development.
In the United States a special procedure is required to obtain the pharmaceutical. In most other countries a consent form is required which explains these risks. Women taking isotretinoin must not get pregnant during, and for 1 month after isotretinoin therapy. Sexual abstinence, or effective contraception is mandatory during this period. Barrier methods by themselves (such as condoms) are not considered adequate due to the unacceptable failure rates of approximately 3%. Women who fall pregnant whilst on isotretinoin therapy are generally counselled to have a termination. Isotretionin has no effect on male reproduction.
There is little evidence in the medical literature linking isotretinoin use with depression and suicide. Despite this, there exists a popular misconception amongst the public that isotretinoin use commonly causes depression.
In 2009, Roche decided to remove Accutane from the US market after juries had awarded millions of dollars in damages to former Accutane users over inflammatory bowel disease claims. Other common brands are Roaccutane (Hoffman-La Roche, known as Accutane in the United States before July 2009), Amnesteem (Mylan), Claravis (Barr), Isotroin (Cipla) or Sotret(Ranbaxy).
Actavis submits ANDAs for two more generic version of Bayer’s Safyral and Fresenius Kabi’s Diprivan (propofol) injection
Actavis submits ANDAs for two more generic version of
Bayer’s Safyral and
Fresenius Kabi’s Diprivan (propofol) injection
Actavis has filed for US approval for generic versions of a contraceptive and a sedative/anaesthetic.http://www.gabionline.net/Generics/News/Actavis-submits-ANDAs-for-two-more-generics
New Drug Approvals 