Alembic Pharma gets US FDA nod for ophthalmic solution
The approved product is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.09 per cent,…
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ANDA
30 Per cent of ANDAs approved by the US FDA in the year 2016 are from India
The Pharmaceuticals Export Promotion Council of India (Pharmexcil), is working on a zero-dependent manufacturing mechanism to…
Zydus’ Nesher Pharma gets US FDA nod for dextroamphetamine IR tabs
The drug is used in treating nervous system disorders, in the US market
Ajanta Pharma gets US FDA nod for migraine pain relief drug
Ajanta Pharma USA is scheduled to launch the almotriptan malate tablets in the US shortly
Ajanta Pharma has received final…
Aurobindo Pharma gets US FDA approval for norethindrone acetate tabs
The tablets are used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary…
Aurobindo Pharma receives US FDA approval for allergic conjunctivitis solution
The approved product has an estimated market size of $235 million
Aurobindo Pharma receives USFDA approval for methylprednisolone sodium succinate injection
The approved product has an estimated market size of $102 million for the twelve months ending October 2015 according to IMS…
Aurobindo Pharma receives US FDA approval for tramadol hydrochloride extended-release tabs
Tramadol hydrochloride tabs are used in the treatment of moderate-to-severe pain in adults
Aurobindo Pharma has received final…
Jubilant Life Sciences gets US FDA nod
The drug is indicated for the acute treatment of migraine in adults and paediatric patients
Jubilant Life Sciences has received…
Jubilant Life Sciences gets US FDA nod for anti-migraine tablets
The company's drug is a generic version of AstraZeneca's Zomig-ZMT tablets, which is used for acute treatment of migraine…