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BIO EQUIVALENT GENERIC
Ajanta Pharma gets USFDA nod for migraine pain relief drugAjanta Pharma has received final approval for its generic version of acute migraine pain relief drug Zolmitriptan tablets from the US healt...
Aurobindo Pharma gets US Food and Drug Administration nod for two drugsThe drug is bio-equivalent and therapeutically equivalent to the reference listed product Pepcid AC Tablets -- 10 mg and 20 mg of McNeil Co...
Germany suspends marketing of 54 drugs tested by GVK BiosciencesGermany's drug regulator has suspended the marketing of 54 medicines clinically tested by India's GVK Biosciences in compliance.
EU bans 700 generic drugs for manipulation of trials by GVK BiosciencesMedicines affected by the sales ban will lose their validity for use in the EU and they should no longer be sold by pharmaceutical companie...
Lupin submits fresh studies for two products suspended by EMALupin said that company has successfully conducted the new bio equivalence (BE) studies for the said products and submitted the report to E...
Germany bans 80 generic drugs for insufficient trials by GVKThe regulator said it had informed the drugs manufacturers about its decision on Monday and the ban on the sales of medicines came into eff...
USFDA approves DRL's Azacitidine for injectionAzacitidine is used to treat certain types of bone marrow cancers and blood cell disorders. Dr Reddy's Azacitidine for injection is availab...
- Dr Reddy's launches generic antihistamine tablets in US
Drug firm Dr Reddy's Laboratories today said it has launched generic antihistamine desloratadine tablets in the American market.
- Dr Reddy's Laboratories launches generic anti-asthma drug in US market
Dr Reddy's Laboratories has launched its generic Montelukast Sodium oral granules used for treating asthma and seasonal allergies in the US...
- Dr Reddy's launches Amoxicillin tablets, capsules in US market
Dr Reddy's today announced the launch of antibiotic Amoxicillin tablets, capsules and oral suspension.
- Dr Reddy's launches osteoporosis tablets in US
Dr Reddy's Laboratories today said it has launched generic tablets used for treating post- menopausal osteoporosis in the American market.
- DRL seeks USFDA help to make cancer drug clone
US-based biotech firm Celgene, the innovator, has declined to make the drug samples available to DRL for bio-equivalence studies.
- Ranbaxy receives nod for Tamsulosin Hydrochloride capsules in Canada
Ranbaxy Laboratories has received approval to manufacture and market Tamsulosin Hydrochloride capsules in 0.4 mg strength from Health Canad...
- Sun Pharm gets USFDA nod for generic Sinemet CR
Sun Pharmaceutical today said it has received US Food and Drug Administration's (USFDA) approval for its abbreviated new drug application (...
- Pharma cos eyeing US generic drugs space
At a time when the US generic drugs market is reeling under price competition, a recent move by the US government to accelerate approvals o...
- Strides Arcolab terminates JV pact with ABP
Strides Arcolab said it has terminated the joint venture agreement with Accu-Break Pharmaceuticals Inc (ABP), which intended to develop gen...
- Gilead’s anti-AIDS drug to cost $1 a day here
Viread, the largest selling anti-HIV/AIDS drug in the United States, will be available to patients in India at a special price equivalent o...