Unichem Laboratories receives FDA approval on asthma drug
Unichem Laboratories has received the final go ahead from FDA to manufacture the generic version Merck Sharp & Dohme Corp's Singulair tablets. These tablets are used in the treatment of asthma.
Drug firm Unichem Laboratories has received approval from the US health regulator for its Montelukast Sodium tablets used in prevention and chronic treatment of asthma, as confirmed by the PTI.
"The company has received ANDA approval for Motelukast Sodium tablets from the United States Food and Drug Administration (USFDA)," Unichem Laboratories said in a filing to BSE.
The product will be commercialised from the company's Goa plant, it added.
The product is generic version of Merck Sharp & Dohme Corp's Singulair tablets in the strength of 10 mg, Unichem said.
Montelukast is used for prevention and chronic treatment of asthma, prevention of exercise induced bronchoconstriction and allergic rhinitis, it added.
Drug firm Unichem Laboratories has received approval from the US health regulator for its Montelukast Sodium tablets used in prevention and chronic treatment of asthma, as confirmed by the PTI.
"The company has received ANDA approval for Motelukast Sodium tablets from the United States Food and Drug Administration (USFDA)," Unichem Laboratories said in a filing to BSE.
The product will be commercialised from the company's Goa plant, it added.
The product is generic version of Merck Sharp & Dohme Corp's Singulair tablets in the strength of 10 mg, Unichem said.
Montelukast is used for prevention and chronic treatment of asthma, prevention of exercise induced bronchoconstriction and allergic rhinitis, it added.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.