Zydus Lifesciences gets FDA final approval for Varenicline Tablets
Zydus Lifesciences has been granted final approval from the US Food and Drug Administration (FDA) to manufacture and market Varenicline Tablets, 0.5 mg and 1 ... Read More
Zydus Lifesciences’ Diclofenac Sodium and Misoprostol Tablets gets FDA final approval
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets ... Read More
Granules India gets FDA approval for generic epilepsy drug Levetiracetam
Granules India has announced its receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam ... Read More
Natco Pharma wins FDA approval for generic colorectal cancer drug
Indian pharmaceutical firm Natco Pharma has gained the US Food and Drug Administration (FDA)'s final approval for its abbreviated new drug application (ANDA) for Tipiracil ... Read More
Zydus Lifesciences’ Ahmedabad plant passes FDA inspection with no observations
AHMEDABAD, INDIA - Indian lifesciences company, Zydus Lifesciences, announced on Tuesday that its injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad has passed ... Read More
Ipsen gets Bylvay FDA approval for cholestatic pruritus in Alagille syndrome
The US Food and Drug Administration (FDA) has granted approval to French biopharmaceutical company Ipsen for Bylvay (odevixibat) for the treatment of cholestatic pruritus in ... Read More
FDA greenlights Granules India’s Metoprolol Succinate ER tablets
Granules India Limited announced its receipt of US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) of Metoprolol Succinate Extended-Release ... Read More
Caplin Point to tap into $35m market after FDA approval for NIMBEX generic
Caplin Steriles, a subsidiary of India's Caplin Point Laboratories, has obtained final approval from the US Food and Drug Administration (FDA) for its generic version ... Read More
AVATAR MEDICAL virtual reality surgical planning solution gets FDA clearance
French medtech startup AVATAR MEDICAL announced that its virtual reality (VR) surgical planning solution has received 510(k) clearance from the US Food and Drug Administration ... Read More
Lupin obtains FDA approval for generic version of Ocaliva Tablets
Indian pharmaceutical company Lupin has announced its approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Obeticholic ... Read More