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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Glenmark Generics receives final ANDA approvals for Zolmitriptan Tablets, 2.5 and 5mg and Zolmitriptan Orally Disintegrating Tablets, 2.5 and 5mg
May 15, 2013: Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approvals (ANDA’s) from the United States Food and Drug
Administration (US FDA) for Zolmitriptan Tablets, 2.5 and 5mg and Zolmitriptan Orally Disintegrating Tablets, 2.5 and 5mg. Glenmark will commence distribution of the product immediately.
Zolmitriptan Tablets and Zolmitriptan ODT are Glenmark’s generic versions of Zomig® and Zomig ZMT® by AstraZeneca, indicated for the acute treatment of migraine headaches in adults.
According to IMS Health for the 12 month period ending December 2012, the products garnered annual sales of USD 176 million.
Teva and Alexza Announce Teva’s License to Market ADASUVE® in the U.S.
Loxapine (Loxapac, Loxitane)
is a typical antipsychotic medication, used primarily in the treatment of schizophrenia. It is a member of the dibenzoxazepine class and structurally related to clozapine (which belongs to the chemically akin class ofdibenzodiazepines). Several researchers have argued that Loxapine may behave as anatypical antipsychotic.
Loxapine may be metabolized by N-demethylation to amoxapine, a tetracyclic antidepressant.
Adasuve® (loxapine) inhalation powder is approved in the U.S. for the acute treatment of agitation associated with schizophrenia and bipolar disorder
May 8, 2013
Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd (NYSE: TEVA), and Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) announced today that the companies have entered into an exclusive U.S. license and supply agreement for ADASUVE (loxapine) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Teva will be responsible for all U.S. commercial and clinical activities for ADASUVE, including U.S. post-approval clinical studies, and has gained rights to conduct additional clinical trials of ADASUVE for potential new indications in neurological disorders. Alexza will be responsible for manufacturing and supplying ADASUVE to Teva for commercial sales and clinical trials.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions, including agitation, acute repetitive seizures and insomnia. Alexza’s products are based on the Staccato®system, a hand-held inhaler that is designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.
Shire move delays Intuniv generic until 2014
Guanfacine (brand name Tenex, and the extended release Intuniv) is a sympatholytic. It is a selective α2A receptor agonist. These receptors are concentrated heavily in the prefrontal cortex and the locus coeruleus, with the potential to improve attention abilities via modulating post-synaptic α2A receptors in the prefrontal cortex. Guanfacine lowers both systolic and diastolic blood pressure by activating the central nervous system α2A norepinephrine autoreceptors, which results in reduced peripheral sympathetic outflow and thus a reduction in peripheral sympathetic tone. Its side-effects are dose dependent, with practically no dryness of the mouth at doses of 2 mg and less
April 26, 2013
Shire has come to an agreement with drugmakers Actavis and Watson that lays to rest all pending litigation over their attempts to launch a generic form of the attention-deficit hyperactivity drug (ADHD) Intuniv (guanfacine hydrochloride) in the US.
Under the settlement, Shire has granted Actavis a license to make and market its version of Intuniv in the US from December 1 next year, in return for a 25% royalty on gross profit during the 180 day period of exclusivity.
read more at—–http://www.pharmatimes.com/Article/13-04-26/Shire_move_delays_Intuniv_generic_until_2014.aspx
FDA OKs Sun Pharma for Generic Januvia, Glumetza
Sun Pharma announces tentative USFDA approvals for generic Januvia® and generic Glumetza®
SUNPHARMA, BSE: 524715) announced that the US FDA has granted its subsidiary, two tentative approvals for its Abbreviated New Drug Applications (ANDA) for generic version of Januvia®, Sitagliptin Tablets and generic version of Glumetza®, Metformin HCl Extended-release tablets.
read more at pharmalive
http://www.pharmalive.com/fda-oks-sun-pharma-for-generic-januvia-glumetza
Lupin Launches its Oral Contraceptive Daysee™ Tablets in the US Market; Generic of Seasonique® Tablets
MUMBAI, India and BALTIMORE, April 12, 2013
Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals Inc. (collectively Lupin) has received final approval for its Daysee™ Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg) from the United States Food and Drugs Administration (US FDA) to market a generic version of Teva Branded Pharm.’s Seasonique Tablets®. Lupin has already commenced shipping the product.
Lupin’s Daysee™ Tablets is indicated for use by women to prevent pregnancy.
Lupin’s Daysee™ Tablet (Levonorgestrel and Ethinyl estradiol tablets USP 0.15 mg/0.03 mg and Ethinyl estradiol tablets USP 0.01 mg) is available in Extended-Cycle Wallets each containing a 13-week supply of tablets: 84 light blue tablets, each containing 0.15 mg of Levonorgestrel and 0.03 mg of Ethinyl estradiol, and 7 mustard tablets, each containing 0.01 mg of Ethinyl estradiol. The light blue tablets are round, biconvex, film-coated tablets, debossed with “LU” on one side and “V21” on the other side. The mustard tablets are round, biconvex, film-coated tablets debossed with “LU” on one side and “V22” on the other side.
The total sales for Branded and generic sales for the product stood at USD 161 million (IMS MAT Dec 2012).
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.
Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).
For the financial year ended March 2012, Lupin’s Consolidated Total Income and Profit after Tax were Rs. 70,972 million (USD 1.49 billion) and Rs.8,676 million (USD 182 million) respectively. Please visit http://www.lupinworld.com for more information.
Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited. Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com.
Dr. Reddy’s launches Zenatane (Isotretinoin Capsules USP) in US
Isotretinoin
1 APRIL, 2013
India-based Dr. Reddy’s Laboratories has announced the launch of Zenatane (Isotretinoin Capsules USP) in 20mg and 40mg strengths in the US.
The launch follows the FDA approval of the company’s ANDA for Zenatane 10mg, 20mg and 40mg.
Zenatane (Isotretinoin Capsules USP) is a generic version, therapeutically equivalent to Accutane (Isotretinoin Capsules USP).
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne.
The company is making the product available in 10mg, 20mg, and 40mg strengths in boxes of 30 as unit dose blisters.
Isotretinoin, first marketed as Accutane byHoffmann-La Roche, is a medication used mostly for cystic acne. It is also achemotherapy treatment used in brain, pancreatic and other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. Its effects are systemic and nonselective. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body.
Isotretinoin’s best-known and most dangerous side effect is birth defects due to in utero exposure. This is 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 (see below).
In 2009, Roche decided to pull Accutane off the US market after juries had awarded millions of dollars in damages to former Accutane users over inflammatory bowel disease claims. Among others, actor James Marshall sued Roche over Accutane-related disease that resulted in removal of his colon.
The most 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).
FOUNDER
LATE DR ANJI REDDY
InnoPharma Inc. Announces Launch of Generic Cidofovir Injection in the United States
({[(S)-1-(4-amino-2-oxo-1,2-dihydropyrimidin-1-yl)-3-hydroxypropan-2-yl]oxy}methyl)phosphonic acid
Cidofovir
Cidofovir is an injectable antiviral medication for the treatment of cytomegalovirus (CMV)retinitis[1] in patients with AIDS. It suppresses CMV replication by selective inhibition of viral DNA polymerase and therefore prevention of viral replication and transcription.[2] It is an acyclic nucleoside phosphonate, and is therefore independent of phosphorylation by viral enzymes,[3] in contrast to, for instance, acyclovir.
Maintenance therapy with cidofovir involves an infusion only once every two weeks, making it a convenient treatment option. Because dosing is relatively infrequent, a permanent catheter is not necessary for infusions.
Cidofovir was discovered at the Institute of Organic Chemistry and Biochemistry, Prague, by Antonín Holý, and developed by Gilead Sciences and is marketed with the brand name Vistide by Gilead in the USA, and by Pfizer elsewhere.
Synthesis
Brodfuehrer, P; Howell, Henry G.; Sapino, Chester; Vemishetti, Purushotham (1994). “A practical synthesis of (S)-HPMPC”.Tetrahedron Letters 35 (20): 3243. doi:10.1016/S0040-4039(00)76875-4.
March 8, 2013 — InnoPharma, Inc. today announced the launch of cidofovir injection (generic equivalent of Vistide(r)) in 5mL single-use vials. InnoPharma developed the generic formulation of cidofovir, which will be marketed in the United States by Mylan, Inc.
Cidofovir injection is indicated for the treatment of cytomegalovirus
(CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). For more information regarding this product, including its black box warning, please refer to the Mylan website at http://www.mylan.com.
About InnoPharma, Inc.
InnoPharma is a sterile product development company, focused on developing complex generic and innovative specialty pharmaceutical products in injectable and ophthalmic dosage forms. The Company has a broad portfolio of products under development, with formulations including solutions, suspension, lyophilized, emulsions, liposomes, micelles and lipid complexes. InnoPharma’s pipeline includes small molecules with solubility and stability challenges, as well as difficult to produce and characterize polypeptides and carbohydrates.
The Company has a comprehensive infrastructure for the development of its products in its state of the art R&D facilities in New Jersey, with the capability to handle potent and cytotoxic molecules. More information can be found at http://www.innopharmainc.com.
- Becker MN, Obraztsova M, Kern ER, et al. (2008). “Isolation and characterization of cidofovir resistant vaccinia viruses”.Virol. J. 5: 58. doi:10.1186/1743-422X-5-58. PMC 2397383.PMID 18479513.
- Cidofovir VIRUSES, HIV, PRIONS, AND RELATED TOPICS. Human Virology at Stanford University
- The mechanism of action of cidofovir and HSV helicase–primase complex inhibitors. Nature reviews
Generic – Dr. Reddy’s Announces the Launch of Zoledronic Acid Injection equivalent of Navartis AG Zometa®
Zoledronic acid
Mar 5, 2013 –
Dr. Reddy’s Laboratories announced today that it has launched Zoledronic Acid Injection (4 mg/5 mL), a bioequivalent generic version of Zometa® (zoledronic acid) 4 mg/5 mL Injection in the US market on March 4, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Zoledronic Acid Injection (4 mg/5 mL).
Dr. Reddy’s Zoledronic Acid Injection 4 mg/5mL is available in a single use vial of concentrate.
Zoledronic acid (INN) or zoledronate (marketed by Novartis under the trade names Zometa, Zomera, Aclasta and Reclast) is a bisphosphonate. Zometa is used to prevent skeletal fractures in patients with cancers such as multiple myeloma and prostate cancer, as well as for treating osteoporosis.It can also be used to treat hypercalcemia of malignancy and can be helpful for treating pain from bone metastases.
An annual dose of zoledronic acid may also prevent recurring fractures in patients with a previous hip fracture.
Reclast is a single 5 mg infusion for the treatment of Paget’s disease of bone. In 2007, the U.S. Food and Drug Administration (FDA) also approved Reclast for the treatment of postmenopausal osteoporosis.
About Dr. Reddy’s Laboratories Ltd.
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to: http://www.drreddys.com
Zometa® is a registered trademark of Novartis AG
NDA-US Marketing by Ranbaxy, Alembic has announced that it has received an NDA approval for extended release version of Pfizer’s anti depressant drug Pristiq, Desvenlafaxine Base
DESVENLAFAXINE
read at
5 march 2013
Alembic has announced that it has received an NDA approval for extended release version of Pfizer’s anti depressant drug Pristiq. Pristiq sell approximately $550m in the US. Alembic has outlicensed rights to Ranbaxy for marketing in the US. The company will start marketing the product immediately.
Alembic will manufacture and supply the drug to Ranbaxy for marketing in the US. Vadodara-based pharma player, Alembic Pharmaceuticals Limited has received the approval from the US Food and Drug Administration (USFDA) for a bioequivalent version of Pristiq by Pfizer.
New Drug Approvals